Cuff electrode

ABSTRACT

A cuff electrode includes at least an array of electrodes to extend circumferentially about a nerve, and methods of making and using a cuff electrode.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/485,954, filed Aug. 14, 2019, which is a 35 U.S.C. § 371 NationalPhase application, and claims priority to, PCT Application No.PCT/US18/46100, filed Aug. 9, 2018, which claims the benefit of U.S.Provisional Patent Application No. 62/544,140, filed Aug. 11, 2017, allof which are incorporated herein by reference in their entireties.

BACKGROUND

Treating sleep disordered breathing has led to improved sleep qualityfor some patients.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view schematically representing an example cuffelectrode.

FIG. 2 is a sectional view schematically representing the example cuffelectrode of FIG. 1 as taken along lines 2-2.

FIG. 3 is a sectional view schematically representing the example cuffelectrode FIG. 1 as taken along lines 3-3.

FIG. 4 is a diagram including an isometric view schematicallyrepresenting different portions of an example cuff electrode.

FIG. 5A is a diagram including an isometric view schematicallyrepresenting an example device including different portions of a cuffbody and an electrode pattern of the cuff electrode of FIG. 4.

FIG. 5B is a diagram including a sectional view schematicallyrepresenting relative arc lengths of circumferential portions of anexample cuff body.

FIG. 6A is a diagram including a sectional view schematicallyrepresenting an example cuff electrode relative to nerve groups within anerve.

FIG. 6B is diagram including a sectional view as taken along lines 6B-6Bof FIG. 6A and schematically representing an electrode array of anexample cuff electrode.

FIGS. 7A-7K is a series of diagrams, each schematically representingdifferent example electrical stimulation vectors and/or example methods.

FIG. 8A is an isometric view schematically representing an example cuffelectrode.

FIG. 8B is a diagram schematically representing an example electrodepattern of the cuff electrode of FIG. 8A.

FIG. 9 is a sectional view schematically representing the example cuffelectrode of FIG. 8A, as taken along lines 9-9.

FIG. 10 is an isometric view schematically representing an example cuffelectrode.

FIG. 11 is a diagram schematically representing an example electrodepattern of the cuff electrode of FIG. 10.

FIG. 12 is an isometric view schematically representing an example cuffelectrode.

FIG. 13A is a diagram schematically representing an example electrodepattern of the cuff electrode of FIG. 12.

FIG. 13B is a diagram schematically representing an example electrodepattern of the cuff electrode of FIG. 12.

FIG. 14A is a sectional view schematically representing an example cuffelectrode including some electrodes partially housed withininwardly-oriented protrusions of a nerve-contact surface.

FIG. 14B is a sectional view schematically representing an example cuffelectrode including some electrodes partially housed withininwardly-oriented protrusions of a nerve-contact surface.

FIG. 15A is a diagram including a plan view schematically representing anerve-contact surface of an example cuff electrode and example electrodepattern relative to some circular-shaped inwardly-oriented protrusionsof the nerve-contact surface.

FIG. 15B is a diagram including a plan view schematically representing anerve-contact surface of an example cuff electrode and example electrodepattern relative to some elongate inwardly-oriented protrusions of thenerve-contact surface.

FIG. 15C is a diagram including a plan view schematically representing anerve-contact surface of an example cuff electrode and example electrodepattern relative to some circular-shaped inwardly-oriented protrusionsof the nerve-contact surface.

FIG. 15D is a diagram including a plan view schematically representing anerve-contact surface of an example cuff electrode and example electrodepattern relative to some elongate inwardly-oriented protrusions of thenerve-contact surface.

FIG. 16 is a diagram including an isometric view schematicallyrepresenting different portions of an example cuff body.

FIG. 17A is a diagram including a plan view schematically representing anerve-contact surface of an example cuff electrode and example electrodepattern relative to some circular-shaped inwardly-oriented protrusionsof the nerve-contact surface.

FIG. 17B is a diagram including a plan view schematically representing anerve-contact surface of an example cuff electrode and example electrodepattern relative to some circular-shaped inwardly-oriented protrusionsof the nerve-contact surface.

FIG. 17C is a diagram including a plan view schematically representing anerve-contact surface of an example cuff electrode and example electrodepattern relative to some elongate inwardly-oriented protrusions of anerve-contact surface.

FIG. 18A is a sectional view schematically representing an example cuffelectrode including some electrodes partially housed withinoutwardly-oriented protrusions.

FIG. 18B is a sectional view schematically representing an example cuffelectrode including some electrodes partially housed withinoutwardly-oriented protrusions.

FIG. 19A is block diagram schematically representing an example fullyimplantable neurostimulation system including a pulse generator, lead,and cuff electrode.

FIG. 19B is block diagram schematically representing an exampleneurostimulation system including a pulse generator and leadless cuffelectrode.

FIG. 20 is a block diagram schematically representing an example controlportion.

FIG. 21 is a block diagram schematically representing an example userinterface.

FIGS. 22A-22U are each a flow diagram, or a portion of a flow diagram,schematically representing an example method.

FIG. 23 is a diagram schematically representing an example nerve branchconfiguration at which an example cuff electrode may be mounted.

FIG. 24 is a diagram schematically representing an example cuffelectrode including a distal extension engaged relative to an examplenerve branch configuration.

FIG. 25 is a diagram schematically representing an example cuffelectrode including a distal extension.

FIG. 26 is a diagram schematically representing an example cuffelectrode including a distal extension.

FIG. 27 is a diagram schematically representing an example cuffelectrode including a distal extension.

FIGS. 28A-28E are each a flow diagram, or a portion of a flow diagram,schematically representing an example method.

FIGS. 29A-29B are each a flow diagram, or a portion of a flow diagram,schematically representing an example method.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific examples of the present disclosure whichmay be practiced. In this regard, directional terminology, such as“top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., may beused with reference to the orientation of the Figure(s) being described.Because components of at least some examples of the present disclosurecan be positioned in a number of different orientations, the directionalterminology is used for purposes of illustration and is in no waylimiting. It is to be understood that other examples may be utilized andstructural or logical changes may be made without departing from thescope of the present disclosure. The following detailed description,therefore, is not to be taken in a limiting sense.

In at least some examples, a cuff electrode includes an electrode arraysuited to selective stimulation profiles which may enhance electricalstimulation of a nerve. In some examples, the nerve comprises anairway-patency-related nerve to treat sleep disordered breathingbehavior. In some examples, the airway-patency-related nerve comprises anerve which innervates a tongue muscle. In some examples, the nervecomprises the hypoglossal nerve. Accordingly, in at least someinstances, the airway-patency-related nerve may sometimes be referred toas an upper-airway-patency-related nerve.

In some examples, the cuff electrode comprises a cuff body supporting atleast one array of first electrodes extending axially along a length ofthe cuff body in a first orientation. In some examples, the cuffelectrode includes at least one array of second electrodes extending ina second orientation generally perpendicular to the first orientation.The second orientation may sometimes be referred to as a circumferentialorientation while the first orientation may sometimes be referred to asan axial orientation. In some examples, one of the first electrodes ofthe axially-extending array functions as one of the second electrodes ofthe circumferentially-extending array.

In some examples, other than the array of axially-extending firstelectrodes, the cuff electrode omits any other electrodes (or otherelectrically conductive materials) in the portions of the cuff bodywhich extend proximally and extend distally relative to the array ofcircumferentially-extending second electrodes. Via this arrangement,such electrically-conductive-free portions of the cuff body may act aselectrical insulative portions to minimize stimulation towardnon-targeted nerve branches and surrounding non-nerve tissues. Inaddition, as part of the overall cuff body, theseelectrically-conductive-free portions act to mechanically secure theelectrodes relative to the nerve. Moreover, via this arrangement, thecuff body retains high flexibility in its distal and proximal portions,thereby contributing to maneuverability of the cuff electrode duringimplantation.

In various other examples, a cuff electrode comprises additionalelectrodes and/or electrode arrays to provide more combinations ofselectable electrodes.

These examples, and additional examples, are described in more detail inassociation with at least FIGS. 1-29B.

FIG. 1 is an isometric view schematically representing a cuff electrode100, according to one example of the present disclosure. As shown inFIG. 1, the cuff electrode 100 comprises a cuff body 101 including afirst arm 134 and a second arm 150, which together form a re-closablelumen 140. In some examples, an end 135 of the first arm 134 and an end151 of the second arm 150 are releasably engageable relative to eachother to at least partially define the re-closable lumen 140. It will beunderstood that in some examples, the point of releasable engagement 109may be located at other positions about the circumference of there-closable lumen 140, with the respective arms 134, 150 havingdifferent relative lengths (than shown in FIG. 1) to implement theparticular location of releasable engagement of the ends of therespective arms 134, 150. It will be understood that for illustrativeclarity FIG. 1 depicts a small gap at the point of releasable engagement109, even though in at least some examples the ends 135, 151 may betouching each other.

In some examples, cuff body 101 comprises a third arm 160 which overlapssecond arm 150 and first arm 134, as further described later inassociation with at least FIG. 2.

As shown in FIG. 1, in some examples, cuff electrode 100 comprises afirst array 102 of spaced apart electrodes 103A, 103B, 103C extendingaxially along a length of the cuff body 101 and a second array 112 ofelectrodes 113A-1130, which extends circumferentially about anerve-contact surface 143 of lumen 140. In some examples, the electrodes103A, 103B, 103C of the example first array 102 may sometimes bereferred to as first electrodes. In some examples, the electrodes 113A,113B, 113C of the example second array 112 may sometimes be referred toas second electrodes.

In some examples, the electrodes 113A, 113B, 113C extend in the samecross-sectional plane (e.g. a single cross-sectional plane), as furthershown later in at least FIGS. 2, 5B, 6A, etc. The respective electrodes103A-1030, 113A-113C are at least partially exposed on nerve-contactsurface 143 of lumen 140, such as shown in FIG. 1 and later shown in atleast FIGS. 6A-6B and/or FIG. 9. In some examples, electrode 103B offirst array 102 functions as (i.e. is the same physical element)electrode 113B in the second array 112. In some examples, the variouselectrodes have generally the same size and/or shape. In some examples,at least some of various electrodes may be differently sized and/ordifferently shaped than other electrodes.

In some examples, electrode 113A is supported on second arm 150 whileelectrode 113C is supported on first arm 134 while electrodes 103A-103Care supported on a proximal portion of first arm 134 and/or a topportion of base 120. The base 120 supports and/or at least partiallydefines a junction of the proximal portions of the respective first andsecond arms 134, 150. While not shown for illustrative clarity, base 120may house electrically conductive elements which extend from lead 82 andat least partially through a length (e.g. L1) of the base 120 forconnection to electrodes 103A-1030, 113A-113C. In some instances, base120 also may sometimes be referred to as a spine.

In some examples, an electrode of the cuff electrode 100 may sometimesbe referred to as an electrode contact because each electrode includesan electrically conductive contact surface intended to engage tissue,such as an outer surface of a nerve, through which electricalstimulation is to be applied.

Accordingly, with reference to at least FIG. 1, in some examples theinner electrodes 113A, 113B (103B), 113C of thecircumferentially-oriented array 112 comprises three independentlyprogrammable electrodes while the outer electrodes 103A, 103C areelectrically common with each other, such that the cuff electrode 100has four independently programmable functional electrodes. In someexamples, via this arrangement the outer electrodes 103A, 103C may beoperated as anodes such that cuff electrode 100 provides a guardedcathode arrangement with the inner axial electrodes 113A, 113B (103B),113C selectively operable as cathodes.

In some examples, the three axially arranged electrodes (e.g. electrode103A, electrode 103C, and at least one of 113A, 1138, 113C electrodes)may implement a guarded bipolar configuration in which positiveelectrodes on the ends of the cuff hyperpolarize the nerve to preventstimulation of non-target tissues. In some examples, the reference topositive electrodes and negative electrodes may refer to the first phaseof biphasic stimulation, e.g. the phase of stimulation intended todepolarize the target nerve.

In some examples, having three inner electrodes 113A, 113B, 113C whichare equally spaced apart in a circumferential orientation may enhanceselective stimulation of particular targeted and non-targeted branchesof a nerve bundle. For instance, via such selective stimulation one mayexclude (e.g. non-target) one of the branches of a target nerve (e.g.hypoglossal nerve). For instance, it may be beneficial in some examplesto not stimulate a branch of the hypoglossal nerve, which would causeretraction of the tongue, with such nerve branches being referred toherein as a retractor nerve branch.

For example, supposing just two circumferentially oriented electrodeswere equally spaced apart (e.g. 180 degrees apart) and a non-targetbranch were located at 90 degree angle relative to each of therespective pair of electrodes, then it may sometimes be difficult toapply a signal with sufficient strength to capture the target nervebranches to achieve the desired muscle response (e.g. tongue protrusion)while still excluding the non-target nerve branches (e.g. tongueretractors).

For example, in some instances a retractor nerve branch may split offfrom the main nerve bundle early such that the retractor nerve isexternal to the remaining nerve bundle at the point at which the cuffbody/electrode 100 is releasably engaged about the main nerve bundle. Insome instances a retractor nerve branch remains within the main nervebundle but is in close proximity to one of the inner electrodes 113A,1138, 113C such that non-activation of the particular electrode 113A,1138, 113C closest to the retractor nerve branch may serve to excludethe retractor nerve branch from stimulation, while activation of theremaining two electrodes (of the three electrodes 113A, 113B, 113C) aresufficient to depolarize the protrusor-related branches of the mainnerve bundle.

In some examples, in some instances in which a targeted nerve branch maybe located at an intermediate position between two of thecircumferentially spaced apart electrodes, an adequate depolarization ofthe target nerve branch may be implemented via applying a high strengthsignal at one electrode. In some examples, application of a low ormoderate strength signal at the remaining two electrodes may contributeto depolarization of the target nerve branches, as desired. Accordingly,regardless of the particular position of the main target nerve brancheswithin the main nerve bundle, the availability of three electrodes 113A,113B, 113C (which are equally spaced in the circumferential orientation)may ensure some combination of activation of at least some of suchelectrodes to achieve adequate depolarization of target nerve branches.

In some such examples, as noted above and throughout examples of thepresent disclosure, such an electrode configuration may also serve toexclude non-target nerve branches from stimulation in some instances.Moreover, in some examples, via at least some of the electrodes 113A,113B, 113C, hyperpolarization may be implemented to inhibit stimulationof some nerve branches (e.g. retractor nerve branches) or other nervebranches exhibiting a negative response.

In some examples, cuff electrode 100 may be implemented having at leastsome of substantially the same features and attributes as one of thecuff electrodes described in Bonde et al. U.S. Pat. No. 9,227,053,“Self-Expanding Electrode Cuff”, issued on Jan. 5, 2016, and/or in Bondeet al. U.S. Pat. No. 8,340,785, “Self-Expanding Electrode Cuff”, issuedon Dec. 25, 2012, both of which are herein incorporated by reference.

In some examples, the array of first electrodes 103A, 103B, 103C and thearray of second electrodes 113A, 113B (same as 103B), 113C togetherexclusively define all the electrodes supported on the cuff body. Insome examples, the array of first electrodes 103A, 103B, 103C and thearray of second electrodes 113A, 113B (same as 103B), 113C togetherexclusively define all the electrodes supported on an implantablemedical device, which includes the cuff body. In some examples, thisimplantable medical device includes a cuff electrode and an implantablepulse generator. In some examples, this implantable medical deviceincludes a cuff electrode, an implantable pulse generator, and leadextending between the cuff electrode and implantable pulse generator. Insome examples, this implantable medical device includes a cuffelectrode, an implantable pulse generator, a lead extending between thecuff electrode and implantable pulse generator, and a separaterespiration sensor/lead.

FIG. 2 is a sectional view schematically representing the cuff electrodeof FIG. 1 as taken along lines 2-2, according to one example of thepresent disclosure. In some examples, the cuff electrode 100 in FIG. 2comprises at least some of substantially the same features andattributes as cuff electrode 100 in FIG. 1, except for further depictingthe third arm 160 in addition to the respective first and second arms134, 150. As shown in FIG. 2, the distal portion 137 of the first arm134 is bendable (per directional arrow B) and the second arm 150 isbendable (per directional arrow D) to open cuff body 101 to enclose anerve within lumen 140. In addition, in FIG. 2 the third arm 160 isshown in an already-bent position (per directional arrow E) to permitaccess to lumen 140 and to permit selective movement of the first andsecond arms 134, 150. It will be understood that, after manipulation toopen the cuff electrode 100 for mounting a nerve, each of the respectivearms 134, 150, 160 are biased to return to their “closed” positionforming the re-closable lumen 140.

As shown in FIG. 2 and as further described in association with at leastFIGS. 4-5B, in some examples the cuff body 101 may be understood ashaving different portions with boundaries between the respectiveportions represented via dashed lines. It will be understood that in atleast some examples the dashed lines shown in the Figures do notrepresent actual seams or discontinuities in the cuff body. It will befurther understood that other conventions for allocating differentportions of cuff body 101 may be adopted.

For instance, in some examples the cuff body 101 may be viewed as havingdifferent portions along a circumferential orientation (line C), whichis generally perpendicular to an axial orientation (line A in FIGS. 1,3) of the cuff body 101. In some examples, the cuff body 101 may beviewed as having an inner circumferential (IC) portion 182 and two outercircumferential portions 184A, 184B with the respective portions 182,184A, 184B extending throughout the entire length of the cuff body 101.Boundaries between the respective inner circumferential (IC) portion 182and the outer circumferential (OC) portions 184A, 184B are representedvia dashed lines 187A, 187B. The inner circumferential and outercircumferential designations will be further described in associationwith at least FIGS. 5A-5B.

In some examples, the inner circumferential portion 182 corresponds to alocation of the nerve-contact surface 143 at which the electrodes 103A,103B, 103C are located. In one aspect, the inner circumferential portion182 provides for the electrode 113B (i.e. 103B) to have an intermediateposition relative to the respective outer electrodes 113A, 113C.

FIG. 3 is a sectional view schematically representing a cuff electrodeas taken along lines 3-3 of FIG. 1, according to one example of thepresent disclosure. As shown in FIG. 3, in some examples the cuff body101 may be viewed as having different portions extending along an axialorientation, which is generally parallel to a longitudinal axis (line Ain FIG. 1) of the cuff body 101. In some examples, the differentportions may be referred to as an inner axial portion 202 and two outeraxial portions 204A, 204B with each axial portion including one of theelectrodes 103A, 103B, 103C. As further shown at least partially in FIG.3, the inner axial portion 202 also includes the electrodes 113A, 113B,113C of the second array 112.

As further shown in FIG. 3, in some examples an electrically conductiveelement 170 extends through a length of a base 120 of the cuff body 101and is electrically coupled relative to each of the respectiveelectrodes 103A, 103B, 103C. In some examples, the electricallyconductive element 170 may take the form of coil, and includes severalelectrically independent conductive strands 171 such that each electrode103A, 103B, 103C is independently programmable/controllable.

While not shown in FIG. 3 for illustrative simplicity, it will beunderstood that in some examples additional electrically independentconductive elements (e.g. wires) extend from a portion of theelectrically conductive element 170 and are electrically connected tothe electrodes 113A, 113B 113C of the second array 112 in the inneraxial portion 202 of the cuff body 101 such that each electrode 113A,113B (same as 103B), 113C is also independentlyprogrammable/controllable.

In some examples, the additional electrically independent conductiveelements may promote flexibility of the overall cuff structure and maywithstand expected flexing of the cuff body. In some such examples, theadditional electrically independent conductive elements extendingthrough at least a portion of the cuff body may comprise at least someundulating portions and/or otherwise designed to flex.

However, in at least some examples, the “additional” electricallyindependent conductive elements extend circumferentially within theinner axial portion 202 of the cuff body 101. Moreover, in some examplesthese “additional” electrically independent conductive elements do notextend circumferentially within the outer axial portions 204A, 204B ofthe cuff body 101, as further described later in association with atleast FIGS. 4, 5A-5B.

FIGS. 4-5A provide further illustrations of the respective differentportions of cuff body 101. FIG. 4 is a diagram including an isometricview schematically representing different portions of a cuff electrode200 including a cuff body 201, according to one example of the presentdisclosure. Portions of the cuff body 201 are akin to the cuff body 101(FIG. 2). In one aspect, the diagram in FIG. 4 expands on designationsassociated with the schematic representation of the inner and outercircumferential portions 184A, 184B in FIG. 2 and of the inner and outeraxial portions in the sectional view of FIG. 3. In some examples, thepoint of releasable engagement 109 is used as a reference point todefine a boundary between at least some of the different portions of thecuff body 101, 201. However, in some examples other reference points maybe used.

FIG. 5A is a plan view schematically representing a nerve-contactsurface of the cuff electrode 200 of FIG. 4 with the cuff body 201 fullyopened and laid out flat for illustrative purposes.

FIG. 5A depicts different portions of the cuff body 101 with portions252A, 252B, 252C corresponding to a first outer axial (OA) portion 204Aand with portions 254A, 254B, 254C corresponding to a second outer axial(OA) portion 204B. Moreover, portions 250A, 250B, 250C in FIG. 5Acorrespond to inner axial (IA) portion 202. Meanwhile, portions 252B,250B, 254B in FIGS. 4-5A correspond to inner circumferential (IC)portion 182 in FIG. 2. Portions 252A, 250A, 254A in FIGS. 4-5Acorrespond to a first outer circumferential (OC) portion 184A andportions 252C, 250C, 254C in FIGS. 4-5A correspond to a second outercircumferential (OC) portion 184B. With this in mind, in viewing FIG. 5Ait can be seen that any given portion (e.g. 252C) includes both an axialand circumferential designation (e.g. OA and OC).

In some examples, the outer axial portions (e.g. 252A, 252C, 254A, 254C)omit any electrically conductive elements, such as electrodes and/orelectrically conductive elements (e.g. wires) extending to/from anelectrode in a different portion of the cuff body 201. Stateddifferently, any wires which extend in or through the inner axial, outercircumferential portions 250A, 250C of the cuff body 101, 201 do notpass through the outer axial, outer circumferential portions 252A, 252C,254C, 254C of the cuff body 101, 201. In other words, the outer axial,outer circumferential portions of the cuff body 101, 201 are free fromany electrically conductive elements (e.g. wires, traces, etc.). In thisway, these respective portions (e.g. 252A, 252C, 254A, 254C) act aselectrically insulative portions, which in some examples, may contributeto selective stimulation of a target nerve portion by minimizinginadvertent stimulation of non-targeted surrounding tissues

In addition, the omission of electrodes and/or conductive elements (e.g.wires) in the proximal outer axial portions 252A, 252C and the distalouter axial portions 254A, 254C of the cuff electrode 100 may enhanceflexibility of the respective distal and proximal ends of the cuff body101. In some examples, this enhanced flexibility may permit easierplacement of the cuff electrode 100 relative to the nerve and/or mayenhance gentler contact with the nerve. In some examples, the effect ofthese flexibility enhancements may be greater when the cuff electrode101 is placed on more distal portions of the target nerve, such as ahypoglossal nerve. In some such examples, the proximal outer axialportions (e.g. 252A, 252C) and the distal outer axial portions (e.g.254A, 254C) may sometimes be referred to as being more flexible thaninner axial portion (e.g. 250A, 250B, 250C) and/or may sometimes bereferred to as being electrically-conductive-free portions. In some suchexamples, the proximal outer axial portions (e.g. 252A, 252C) and thedistal outer axial portions (e.g. 254A, 254C) are substantially moreflexible, such as 25%, 50%, 75% more flexible, than the inner axialportions (e.g. 252A, 252C). In some such examples, the termsubstantially more flexible may correspond to being 2×, 3×, 4× moreflexible.

While the cuff body 101 is made of a polymeric material which isgenerally electrically non-conductive, in some examples, the proximalouter axial portion 252C and distal outer axial portion 254C furtherincludes additive electrically insulative material to further protectnon-targeted surrounding tissues from unintended stimulation.

By providing this arrangement of just a single array ofcircumferentially-oriented electrodes 113A, 113B, 113C (in addition tothe axially-oriented array of first electrodes 103A-1030) instead of afully cylindrical array (e.g. 3×3, 4×4, etc.), fewer wires extendthrough/within the lead body 82 up to and through the length of the cuffbody 101, which in turn provides for a highly flexible lead suited tothe highly mobile neck structure. By providing a lead body 82 withrelatively high flexibility as it extends through/within the neck region(upon implantation), patient comfort and longevity of the lead body 82may be enhanced because the lead body 82 is able to flex well with themany different positions and frequency of movement of the neck region.

In some examples, as shown in at least FIG. 3, D5 represents the axiallength of the electrically-conductive-free portions (e.g. 252C, 254C,etc.) of cuff body from the inner axial, circumferentially-orientedelectrodes 113A, 113B, 113C to an end 107 of the cuff body 101. In someexamples, this axial length (D5) is substantially greater than a width(W1) of the electrodes 113A, 113B, 113C. In some examples, the axiallength D5 is at least 3 times the width W1. In some examples, the axiallength D5 is at least 4 times the width W1.

In addition, once the cuff electrode 100 is implanted at a desiredlocation along a length of the target nerve (e.g. hypoglossal nerve), insome examples the opposite ends 107, 108 of the cuff body 101, 201 maysometimes lie in close proximity to other nerve branches extending offthe target nerve. By omitting additional electrodes in the proximalouter axial portion (252A, 252C) and the distal outer axial portion(254A, 254C) of the cuff body 201, selective stimulation may be confinedprimarily in an area interior to the opposite ends 107, 108 of the cuffbody 201, which in turn may minimize incidental stimulation of thenon-target nerve branches and/or other surrounding non-nerve tissues.

As further shown in FIG. 5A, the various different portions of cuff body201 are depicted as having a generally uniform width (W2, W3, W4) andgenerally uniform length (L2, L3, L4). However, in some examples thewidths and/or lengths of the various different portions may benon-uniform, such that W3 is greater than W2, W4 is greater than W2,etc. as some non-limiting examples. Moreover, while FIG. 4 depicts thethickness of the wall of the cuff body 101 as having a generally uniformthickness for illustrative simplicity, it will be understood that thethickness of a given portion (e.g. 252A) may vary along its lengthand/or width in some examples and that thickness of one portion (e.g.252A) need not necessarily match a thickness of another portion (e.g.254C).

As shown in the sectional view of FIG. 5B, in some examples, accordingto the circumferential orientation the three respective outer and innercircumferential portions 184A, 184B, 182 have generally equal arclengths (AL1, AL2, AL3), such that each extends about 120 degrees arc ofa 360 degree circumference. It will be understood that the referencenumerals AL1, AL2, AL3 in FIG. 5B correspond to the designators W2, W3,W4 in FIG. 5A. In some examples, the inner circumferential portion 182extends less than a 120 degree arc, such as a 100 degree arc. In someexamples, a first outer circumferential portion 184A (e.g. OC portions252A, 250A, 254A) has a circumferential arc length (AL1; W2) that issubstantially the same as a circumferential arc length (AL3; W4) of thesecond outer circumferential portion 184B (e.g. OC portions 252C, 250C,254C).

However, in some examples, the first outer circumferential portion 184A(e.g. OC portions 252A, 250A, 254A) has a circumferential arc length(AL1; W2) that is different from the circumferential arc length (AL3;W4) of the second outer circumferential portion 184B (e.g. OC portions252C, 250C, 254C). In some examples, the first outer circumferentialportion 184A (e.g. OC portions 252A, 250A, 254A) has a circumferentialarc length (AL1; W2) that is substantially less than a circumferentialarc length (AL3; W4) of the second outer circumferential portion 184B(e.g. OC portions 252C, 250C, 254C) as shown in FIG. 4.

In some examples associated with at least FIGS. 1-5B, a size and/orshape of each of the inner axial portion 202 (portions 250A, 250B, 250C)of the cuff body 201 may be at least partially characterized by havingno more than one electrode (e.g. 113A, 113B (also known as 103B), 113C)and a size and/or shape of each portion 252B, 254B (innercircumferential IC, outer axial OA) of the cuff body 201 may becharacterized as having no more than one electrode (e.g. 103A, 103C,respectively).

However, as later described in association with at least FIGS. 14A, 14B,18A, 18B, in some examples a portion 250A (outer circumferential OC,inner axial IA) of the cuff body 201 omits an electrode (e.g. 113A)while a portion 250C (outer circumferential OC, inner axial IA) of thecuff body 201 includes two electrodes (e.g. 113A, 113C).

While cuff electrode 100 is shown in FIG. 1 as extending from a leadbody 82, it will be understood that in some examples the cuff electrode100 may comprise a leadless cuff electrode 1100, as later shown in FIG.19B. Accordingly, in some examples, the leadless cuff electrode 1100 maycomprise an antenna and/or circuitry for wirelessly communicating with acontrol portion (FIG. 20) and/or a pulse generator 1110 located externalto the patient's body (FIG. 19B) and/or located elsewhere in thepatient's body (FIG. 19A). In some examples, the antenna and/orcircuitry is housed within the base 120 of the cuff body of cuffelectrode 1100.

Accordingly, with reference to at least FIGS. 1-5B, in some examples theinner electrodes 113A, 113B (103B), 113C of thecircumferentially-oriented array comprises three independentlyprogrammable electrodes while the outer electrodes 103A, 103C areelectrically common with each other, such that the cuff electrode 100,200 has four independently programmable functional electrodes. In someexamples, via this arrangement the outer electrodes 103A, 103C may beoperated as anodes such that cuff electrode 100 provides a guardedcathode arrangement with the inner axial electrodes 113A, 113B (103B),113C selectively operable as cathodes.

In some examples, as later shown in FIG. 19A-19B, the cuff electrode100, 200 is associated with an implantable pulse generator (IPG) 1110having an external conductive case, which may selectively act as anelectrode in cooperation with the functional electrodes of cuffelectrode 100.

Via the arrangement of the axial array of electrodes 103A, 103C, and thecircumferentially-oriented array of electrodes 113A, 113B (same as103B), 113C of cuff electrode 100, effective selective stimulation maybe achieved without unduly complicating the associated programming to doso. Moreover, a high degree of selectivity in stimulating various nervefiber groups may be achieved with a relatively small number ofelectrodes.

In some examples, the particular arrangement of electrodes 113A-1130,103A-1030 depicted in at least FIGS. 1-5B may be implemented in a cuffbody having a different configuration of arms than the particulararrangement of arms of cuff body 101, 201 shown in FIGS. 1-5B.

FIG. 6A is a sectional view schematically representing a cuff electrode270 engaged about a nerve 261, according to one example of the presentdisclosure. In at least some examples, FIG. 6A also may be viewed asschematically representing a method of neurostimulation and/or therapyto treat sleep disordered breathing, such as but not limited toobstructive sleep apnea. In some examples, cuff electrode 270 comprisesat least some of substantially the same features and attributes of cuffelectrodes 100, 200 as described in association with at least FIGS.1-5B. This sectional view generally corresponds to the sectional view ofFIG. 2 as taken through inner axial portions 250A, 250B, 250C of cuffbody 101, 201. Among other features, FIG. 6A illustrates that, in atleast some examples, the circumferentially-oriented array of electrodes113A, 113B, 113C are equally spaced apart about circumference ofnerve-contact surface 143 of cuff body 101, 271. It will be understoodthat a nerve-contact surface 143 of cuff electrode 270 is in releasablecontact against an outer surface 263 of nerve 261 with FIG. 6A and thatthe minor spacing shown between the nerve-contact surface 143 and outersurface 263 of nerve 261 are provided for illustrative clarity.

As shown in FIG. 6A, the nerve 261 comprises several nerve fiber groups262A-262D, with the exact number (e.g. 3, 4) of nerve fiber groupsvarying from nerve-to-nerve and dependent on a location along the nerve.In some instances, more nerve fiber groups are present in more proximalportions of a nerve and fewer nerve fiber groups are present in moredistal portions of a nerve pathway. In general terms, the nerve fibergroups 262A-262D may be considered as being arranged in a generallycircumferential pattern. However, the depiction in FIGS. 6A-6B providesjust one example pattern with it being further understood that thevarious nerve fiber groups may have different diameters from each otherand/or may have positions within the nerve casing which vary from thepositions shown in FIG. 6A.

In attempting to electrically stimulate the nerve 261 as a whole, eachof the nerve fiber groups may exhibit different responses than eachother. In some examples, the different responses may be characterized asa non-response, a positive response, or a negative response. A widevariety of factors may influence the degree to which a particular nervebranch responds to electrical stimulation. In some examples, anon-response of a nerve group to electrical stimulation may be caused bya lack of physical contact between an electrode and the nerve or causedby a fluid presence between the electrode and the nerve. In someexamples, a non-response also may be caused by a temporary neurapraxia,in which normal nerve conduction fails for some period of time. In someexamples, a non-response may be caused by prior permanent damage to thenerve bundle or the nerve as a whole. In some examples, other factorsaffecting a non-response may comprise nerve diameter and/or relativedegree of myelination. In some examples, some combination of thesefactors and/or other factors may cause a non-response of a nerve fibergroup(s) to electrical stimulation.

In some examples, a negative response (to electrical stimulation of thenerve via a cuff electrode) may be characterized as a response in whichsome behavior detracts from the intended response. For instance, in someexamples, a negative response may be characterized as an uncomfortablemuscle response, such as an uncomfortable motion of a tongue muscle,and/or abrasion on teeth adjacent to the stimulated tongue muscle. Insome examples, a negative response may be characterized as anundesirable tongue motion, such as retraction of the tongue when atongue protrusion was the intended response.

In some examples, a positive response may be characterized by musclecontraction of a muscle innervated by a target nerve to whichstimulation was intentionally applied via the cuff electrode. In someexamples, a positive response may be characterized by at least onemuscle causing protrusion of the tongue to maintain or restore airwaypatency upon electrical stimulation of an upper airway patency-relatednerve (e.g. hypoglossal nerve) via a particular stimulation vector(s)via one or more electrode combinations of the cuff electrode.

When observing a response to determine whether it is a positiveresponse, a negative response, or a non-response, in at least someexamples the primary response is observed near a cathode of a cuffelectrode and a non-response observed near an anode of the cuffelectrode. In some examples, such as a guarded cathode configuration,the cathode corresponds to one of electrodes 113A, 113B (same as 103B),and/or 113C while the anode corresponds to electrodes 103A, 103C.

Via the circumferentially arranged electrodes 113A, 1138 (same as 103B),113C, the various nerve groups may be selectively stimulated to recruitnerve fiber groups which exhibit a positive response and avoidrecruitment of nerve fiber groups which exhibit negative responses or anon-response.

In doing so, in some examples the targeting of stimulation to inducepositive responses may be implemented via selective stimulation.However, in some examples, the targeting of stimulation may beimplemented via selective hyperpolarization which may act to suppressnegative responses of some nerve fiber groups. In some examples, acombination of selective stimulation and selective hyperpolarization maybe implemented to result in the desired recruitment of and/or inhibitingof particular nerve fiber groups.

In some examples, the path of stimulation may be implemented as a shortstimulation path or as a long stimulation path based on the position ofthe electrodes of the cuff electrode which being employed as anodes. Insome examples, a short stimulation path may provide for better isolationof nerve fiber groups within a nerve. Stated differently, a shortstimulation path may permit more precise targeting of particular nervefiber groups. In some examples, a short stimulation path may beimplemented via using at least some inner electrodes as the anode(s).For instance, in some examples, a short stimulation path may include oneor more of the inner axial electrodes 113A, 113B, 113C as a cathode andat least one of the inner axial electrodes 113A, 113B, 113C as an anode.The later described FIGS. 7G-7H and FIGS. 7I-7K provide some examples ofa short stimulation path.

In some examples, a long stimulation path may permit an increasedresponse level in the targeted nerve fiber groups for a given energylevel delivered to the nerve. In some examples, a long stimulation pathmay include the outer axial electrodes 103A, 103C as anodes and one ofthe inner axial electrodes 113A, 113B (same as 103B), 113C as a cathode.The later described FIGS. 7C-7D and FIGS. 7E-7F provide examples of along stimulation path.

As previously noted, the absence of electrically conductive elements(e.g. electrodes, related connections/wires, etc.) in regions of atleast the “upper” portions (e.g. 252C, 254C) of the cuff body, which aredistal and proximal to the inner axial, circumferentially-oriented arrayof electrodes 113A, 1136, 113C may help to minimize or avoid eliciting aresponse by other nerves and/or other tissue (e.g. muscles) external tothe boundaries of the cuff body.

With such arrangements in mind, as shown in FIG. 6A, in some exampleselectrode 113C may be used to primarily or exclusively stimulate nervefiber group 262A, 262B (e.g. nerve branches 262A, 262B within main nerve261) while electrode 113B may be used to primarily or exclusivelystimulate nerve fiber group 262C. Meanwhile, via such a selectivestimulation arrangement, nerve fiber group 262D may be excluded fromstimulation at least by not activating electrode 113A and controllingthe intensity and area of stimulation field E1, E2 (shown in dashedlines) from electrodes 113C, 1136, respectively so as to not capture andstimulate nerve fiber group 262D. Alternatively, in some examples,hyperpolarization may be applied via electrode 113A to the nerve fibergroup 262D to inhibit activation of nerve fiber group 262D. In examplesin which the particular nerve may be the hypoglossal nerve, in someexamples nerve fiber group 262D may correspond to a nerve fiber group(e.g. branch) controlling retraction of the tongue while in someexamples nerve fiber groups 262A, 262B, and/or 262C may correspond to anerve fiber group (e.g. branch) controlling protrusion of the tongue.

FIG. 6B is side partial sectional view as taken along lines 6B-6B ofFIG. 6A and schematically representing a cuff electrode 270 engaging anerve 261, according to one example of the present disclosure.

FIGS. 7A-7K are a series of diagrams schematically representingstimulation vectors in association with various electrode arrayconfigurations, according to one example of the present disclosure. InFIGS. 7A-7K, an electrode shown in black indicates that the electrode isbeing utilized as part of a selected electrode configuration to producea particular stimulation vector. Electrodes label as “A” are used asanodes, while electrodes labeled as “C” are used as a cathode. It willbe understood that in some examples, during a single treatment period(e.g. one nighttime therapy), multiple different electrodeconfigurations can be employed such that the designation of a particularelectrode(s) as a cathode or anode may change over time depending onwhich electrode configuration is employed at a particular point in time.In some examples, FIGS. 7A-7K also may be viewed as schematicallyrepresenting at least an example method of neurostimulation and/or oftherapy to treat sleep disordered breathing, such as but not limited toobstructive sleep apnea.

As shown in FIGS. 7A-7B, in this particular configuration 280 of activeelectrodes, solely the first array of electrodes 103A-1030 is employedand in which the outer two electrodes 103A, 103C act as anodes while theinner electrode 103B (same as 113B) acts as a cathode. The twoelectrodes 113A, 113C remain inactive.

This active electrode configuration 280 may produce an electricalstimulation pattern as shown. As shown in FIG. 7B, in some such examplesconfiguration 280 may produce a field (shown in dashed lines) in whichtargeted protrusor branches B1, B2 of a nerve (e.g. a hypoglossal nerve)may be captured and stimulated while generally excluding a non-targetedbranch B3 from stimulation. In some examples, the non-targeted branch B3may be non-responsive or exhibit a negative response, as previouslydescribed. In some examples, a negative response may include being aretractor branch.

As shown in FIGS. 7C-7D, in this particular configuration 284 of activeelectrodes, the outer two electrodes 103A, 103C act as anodes while oneof the inner electrodes 113A or 113C acts as a cathode. Electrode 103Bremains inactive, as well as one of the electrodes 113A or 113C.

This active electrode configuration 284 may produce an exampleelectrical stimulation pattern as shown in which a target protrusorbranch B1 may be captured and stimulated while generally excludingnon-targeted branches B2 and B3, which may exhibit a negative responseor non-response.

As shown in FIGS. 7E-7F, in this particular configuration 286 of activeelectrodes, the outer two electrodes 103A, 103C act as anodes while bothof the inner electrodes 113A and 113C may act cathodes. Electrode 103B(same as 113B) remains inactive.

This active electrode configuration 286 may produce an electricalstimulation pattern as shown in which targeted protrusor branches B1 andB3 may be captured and stimulated while generally excluding branch B2which may exhibit a negative response or a non-response. In someexamples, a negative response may include being a retractor branch.

However, in some examples, all three inner electrodes 113A, 113B, 113Cmay be act as cathodes.

As shown in FIGS. 7G-7H, in this particular configuration 288 of activeelectrodes, only the inner electrodes 113A, 113C are active while theouter electrodes 103A, 103C remain inactive.

As shown in FIGS. 7I-7K, in this particular configuration 290 of activeelectrodes, inner electrode 113B (same as 103B) is active along with oneof electrodes 113A (FIG. 7J) or 113C (FIG. 7K) while the outerelectrodes 103A, 103C remain inactive.

With regard to the examples of FIGS. 7A-7K, it will be understood thatin each instance in which stimulation of a particular nerve branch/groupis said to be excluded from stimulation, in some exampleshyperpolarization may be applied to the particular nerve branch/group toinhibit its activation.

FIG. 8A is an isometric view schematically representing a cuff electrode300, according to one example of the present disclosure. In someexamples, cuff electrode 300 comprises at least some of substantiallythe same features and attributes as cuff electrode 100, 200 aspreviously described in association with at least FIGS. 1-7K, excepthaving additional electrodes in portions of cuff body 101, 201 in whichthey were omitted in cuff electrode 100, 200. In particular, as shown inFIG. 8B, electrodes 323A and 323C are present in portions 252A, 252C ofcuff body 301 while electrodes 333A and 333C are present in portions254A, 254C of cuff body 301. With this in mind, cuff electrode 300 inFIG. 8A includes an array 330 of electrodes 323A-323C, 313A-313C,333A-333C in which, in some examples, electrodes 313A, 313C correspondto electrodes 113A, 113B (also 103B), 113C in FIG. 2.

In some examples, each one of the various electrodes 323A-323C,313A-313C, 333A-333C is independently programmable/controllable.Accordingly, in general terms, a large variety of different combinationsof the electrodes of cuff electrode 300 may be activated to stimulatethe nerve.

In some examples, the array 332 of outer electrodes 323A, 323B, 323C areelectrically common with each other in the circumferential orientationand the array 334 of outer electrodes 333A, 333B, 333C are electricallycommon with each other in a circumferential orientation.

In some examples, the first array 332 of electrodes and the second array334 of electrodes are electrically common with each other such that allof the respective electrodes 323A-323C of the first array 332 and therespective electrodes 333A-333C of the second array 334 are programmabletogether as a single electrical element. Meanwhile, each of the innerelectrodes 313A, 313B, 313C are programmable independently relative toeach other, and independent of the respective outer electrodes323A-323C, 333A-333C. Accordingly, in this example the inner electrodes313A, 313B, 313C comprises three independently programmable electrodeswhile the group of electrodes 323A-323C, 333A-333C comprise a singleprogrammable electrode, such that the cuff electrode 300 has fourindependently programmable functional electrodes. In some such examples,this configuration may exhibit lower impedance, which may result in moreefficient and/or effective stimulation, such as via more effectivehyperpolarization of nearby tissues.

In some examples, the cuff electrode 300 is associated with animplantable pulse generator (IPG) 1110 (FIG. 19A-B) having an externalconductive case, which may selectively act as an electrode comparablewith the four functional electrodes of cuff electrode 300.

However, in some examples, the first array 332 of outer electrodes 323A,323B, 323C are electrically common with each other in a circumferentialorientation, but electrically independent of the second array 334 ofouter electrodes 333A, 333B, 333C, with the respective electrodes 333A,333B, 333C being electrically common with each other in acircumferential orientation. Via this arrangement, the first array 332of outer electrodes 323A, 323B, 323C may be activated via a stimulationsignal separate from, and independent of the second array 334 of outerelectrodes 333A, 333B, 333C such that the activation of the first array332 is axially unique relative to activation of the second array 334. Insome such examples, this configuration may exhibit lower impedance,which may result in more efficient and/or effective stimulation, such asvia more effective hyperpolarization of nearby tissues.

FIG. 8B is a diagram including a plan view of the comprehensive array330 of electrodes 323A-323C, 313A-3130, 333A-333C while FIG. 9 providesa sectional view (as taken along lines 9-9 in FIG. 8A) of electrodes313A, 313B, 313C. In some examples, the electrodes 313A, 313B, 313Cshown in FIG. 9 are representative of electrodes 323A, 323B, 323C andelectrodes 333A, 333B, 333C having generally uniform circumferentialspacing relative to each other. However, in some examples, thecircumferential spacing of the electrodes 313A, 313B, 313C may benon-uniform. Moreover, in some examples, instead of having a 3×3electrode matrix, cuff electrode 300 may comprise a 4×4 or 3×5, 4×6,etc. electrode matrix.

In some examples, as shown in FIGS. 8B-9, the cuff body 301 includescircumferential portions (e.g. 250A, 250B, 250C) having substantiallyequal arc lengths (AL5 or W5; AL6 or W6; AL7 or W7). In some examples,at least some of the different circumferential portions have arc lengthswhich vary from each other.

In some examples, the particular arrangement of electrodes depicted inat least FIGS. 8A-9 may be implemented in a cuff body having a differentconfiguration than the cuff body 301 shown in FIGS. 8A-9. In someexamples, the particular arrangement of electrodes depicted in FIGS.8A-9 may be implemented in the cuff body 101 shown in FIGS. 1-3 and/orthe respective cuff bodies shown in FIGS. 14A-14B, 18A, 18B.

In some examples, in a manner similar to that depicted in FIGS. 6A-6B(in which the cuff body releasably contacts a nerve 261) and/or FIGS.7A-7K, the arrangements shown in FIGS. 8A, 8B, 9 also may be viewed asschematically representing a method of neurostimulation and/or therapyto treat sleep disordered breathing, such as but not limited toobstructive sleep apnea. It will be understood that the nerve 261 isomitted in FIGS. 8A, 9 for illustrative clarity in such examples.

FIG. 10 is an isometric view schematically representing a cuff electrode400, according to one example of the present disclosure. In someexamples, cuff electrode 400 comprises at least some of substantiallythe same features and attributes as cuff electrode 300 of FIGS. 8A-9,except for additionally including a pair of ring electrodes 415A, 415Bon opposite ends of the cuff body 401 and on opposite ends of the array330 of electrodes 323A-323C, 313A-313C, 333A-3330. FIG. 10 retains thesection lines 9-9 to reflect that a cuff electrode 400 depicted in FIG.10 may exhibit at least some of substantially the same features andattributes as the cuff electrode 300 represented in the sectional viewof FIG. 9. Moreover, it will be understood that, in a manner similar tothat depicted in FIGS. 6A-6B (in which the cuff body releasably contactsa nerve 261) and/or FIGS. 7A-7K, the arrangements shown in FIGS. 10-11also may schematically represent a method of neurostimulation and/ortherapy to treat sleep disordered breathing, such as but not limited toobstructive sleep apnea. It will be understood that the nerve 261 isomitted in FIGS. 10-11 for illustrative clarity in such examples.

With further reference to FIG. 10, in some examples, each ring electrode415A, 4156 comprises a split ring electrode having a body 416 extendingbetween two opposite ends 417A, 4176, which in turn define a gap G. Insome examples, the gap G is sized and positioned to facilitate openingand closing of the cuff body 401 during implanting the cuff electrode400 to removably encircle a nerve. Accordingly, the gap G in the ringelectrodes 415A, 4156 generally corresponds to and/or overlaps with apoint of releasable engagement (e.g. 109 in FIGS. 1-5B) between opposingarms of the cuff body (e.g. 101 in FIGS. 1-5B).

In some examples, the gap G may have a different circumferentialposition than shown in FIG. 10. For instance, gap G may have acircumferential position such as the particular circumferential positionfor point of releasable engagement 109 of cuff electrode 100 shown in atleast FIGS. 1-5B.

In some examples, the ring electrodes 415A, 4156 have an inner diametergenerally corresponding to a diameter of the lumen 140 defined by cuffbody 401 in its closed position. In some examples, the body 416 of eachring electrode 415A, 4156 has an arc length which corresponds to 70 to90 percent of a circle.

In some examples, the respective ring electrodes 415A, 4156 are retainedin position relative to cuff body 401 and electrodes 323A-323C,313A-313C, 333A-333C via an overmolding, which is independent of thecuff body 401. In some examples, the overmolding comprises apolyurethane material. In some examples, the overmolding extends from alead body which extends proximally and/or distally from the cuff body101. In some examples, this lead body is the same lead body whichsupports cuff electrode 400 and which is at least partially incorporatedwithin base 120 of cuff body 101.

In some such examples, the lead body and/or cuff electrode 400 may bemolded, extruded, adhesively assembled, and/or formed. However, in somesuch examples, the electrode array and non-conduction portions of thecuff electrode 400 may be manufactured via a printed circuitrymanufacturing process and opposing arms of the cuff electrode (and/orother features which may wrap about a nerve) being formed in acomplementary manner with the printed electrode array and non-conductiveportions of the cuff electrode 400.

In some examples, the ring electrodes 415A, 415B are formed from anelectrically conductive material. In some examples, the ring electrodes415A, 451B may be formed from a material which is resilient and/orsemi-rigid.

In some examples, the ring electrodes 415A, 415B may facilitatemaintaining a particular position of cuff electrode 400 along a lengthof the nerve, and may contribute to long term retention of the cuffelectrode 400 on the nerve. In one aspect, the resilient and/orsemi-rigid material forming the ring electrodes 415A, 415B contribute tosuch position maintenance and long term retention. In some examples, thesemi-rigid material forming the ring electrodes 415A, 415B exhibitssufficient stiffness to resist undue bending or flexing duringmaneuvering the cuff electrode 400 into encircling engagement about thenerve.

In some examples, the respective ring electrodes 415A, 415B areindependently programmable/controllable, while in some examples, therespective ring electrodes 415A, 415B are electrically common with eachother.

In some such examples associated with FIG. 10, a greater degree ofselectivity may be implemented via the increased number of electrodesurfaces. In some examples and as previously noted in association withFIG. 10, the respective electrodes 323A, 313A, 333A comprise a firstaxial array 440 while respective electrodes 323B, 313B, 333B comprise asecond axial array 442, and respective electrodes 323C, 313C, 333Ccomprise a third axial array 444.

In some examples, cuff electrode 400 comprises the ring electrodes 415A,415B and just one of the axial arrays 440, 442, 444. In other words, twoof the axial arrays 440, 442, 444 are omitted from cuff electrode 400while retaining the two ring electrodes 415A, 415B.

In some examples, cuff electrode 400 comprises just two of therespective axial arrays 440, 442, 444. In other words, just one of theaxial arrays 440, 442, 444 is omitted from cuff electrode 400 whileretaining the two ring electrodes 415A, 415B.

In such examples, in which one or two of the axial arrays 440, 442, 444are omitted, the remaining axial arrays 440, 442, 444 may be have adifferent position (according to a circumferential orientation) thanshown in FIGS. 10-11.

FIG. 11 is a plan view schematically representing the comprehensivearray 330 of electrodes 323A-323C, 313A-3130, 333A-333C and the pair ofring electrodes 415A, 415B, according to one example of the presentdisclosure. In some examples, each ring electrode 415A, 415B has an arclength (L8) and a width (W8). In some examples, each ring electrode415A, 415B is spaced apart by a distance D1 from an end of thecomprehensive array 330 of electrodes 323A-323C, 313A-3130, 333A-3330.

In some examples, the particular arrangement of electrodes depicted inat least FIGS. 10-11 may be implemented in a cuff body having adifferent configuration of than the cuff body 401 shown in FIG. 10. Insome examples, the particular arrangement of electrodes depicted in FIG.10 may be implemented in the cuff body 101 shown in FIGS. 1-5B and/orthe respective cuff bodies shown in at least FIGS. 14A-14B, 18A-18B.

FIG. 12 is an isometric view schematically representing a cuff electrode500, according to one example of the present disclosure. FIG. 13A is aplan view schematically representing the array 530 of electrodes 520,323B-323C, 313B-313C, and 313B-313C of cuff electrode 500 when laid outflat, according to one example of the present disclosure. FIG. 13B is aplan view schematically representing the array 530 of electrodes 520,323B-323C, 313B-313C, and 313B-313C of cuff electrode 500 as in FIG.13B, except with elongate electrode 520 in a different circumferentialposition relative to the other rows of electrodes (in their axialorientation).

In some examples, cuff electrode 500 comprises at least some ofsubstantially the same features and attributes as cuff electrode 300 aspreviously described in association with at least FIG. 8A-9, excepthaving a single elongate electrode 520 in cuff electrode 500 (FIG. 12)instead of electrodes 323A, 313A, 333A in cuff electrode 300 (FIG. 8A).With this in mind, cuff electrode 500 in FIG. 12 includes an array 530of electrodes 520, 323B-323C, 313B-313C, and 333B-333C. Via thisarrangement, the elongate electrode 520 is common axially to all of theother electrodes 323B-323C, 313B-313C, and 333B-333C of array 530. Insome examples, each one of the various electrodes 520, 323B, 323C, 313B,313C, 333B, and 333C is independently programmable/controllable.Accordingly, in general terms, a large variety of different combinationsof the electrodes of cuff electrode 300 may be activated to stimulatethe nerve.

In some examples, electrodes 323B, 323C are electrically common witheach other to function as a single activatable electrical element,electrodes 3138, 313C are electrically common with each other tofunction as a single activatable electrical element, and electrodes333B, 333C are electrically common with each other to function as asingle activatable electrical element. Via this arrangement, differentaxial points along length of nerve may be stimulated.

In some such examples, this configuration may permit use of lowerstimulation amplitudes via the relatively larger surface area of theelongate third electrode 520. Upon positioning the electrodeconfiguration in at least some locations, this effect, may in turn,increase generator efficiency and may increase nerve capture. In someexamples, the elongate third electrode 520 has a length at leastsubstantially equal to the distance of spacing between two outerelectrodes (e.g. 323C, 333C) of one of the axial arrays of electrodes.As such, in some examples, the elongate third electrode 520 maysometimes be referred to as being generally coextensive with one or moreof the axial arrays of electrodes (e.g. 323C, 313C, 333C). Moreparticularly, in some examples, the elongate third electrode 520 isgenerally coextensive with outer ends 339A, 339B of electrodes 323C,333C. In some examples, the elongate third electrode 520 is generallycoextensive at least through inner ends 338A, 338B of the outerelectrodes (e.g. 323C, 333C) of one of the axial arrays of electrodes.

In some examples, the elongate third electrode 520 has an arc length (inthe circumferential orientation) which is substantially the same as anarc length of the other electrodes of the cuff electrode. However, insome examples, the elongate third electrode 520 has an arc length (inthe circumferential orientation) which substantially greater than thearc length of the other electrodes of the cuff electrode. In some suchexamples, this greater arc length may enable a reduction in overall cufflength, which in turn may enable greater maneuverability of the cuffbody to enhance surgical delivery of the cuff. In some examples, anelongate third electrode 520 may located, in a circumferentialorientation, closer to or overlapping with a spine (e.g. base 120 inFIG. 1) of the cuff/lead so as to minimize any impact on overall cuffflexibility.

In some examples, the particular arrangement of electrodes depicted forcuff electrode 501 in FIG. 12 may be implemented in a cuff body having adifferent configuration than the cuff body 501 shown in FIG. 12. In someexamples, the particular arrangement of electrodes depicted in FIG. 12may be implemented in the cuff body 101, 201 shown in FIGS. 1-6B and/orthe respective cuff bodies shown in FIGS. 14A-14B and 18A, 18B.

FIG. 12 retains the section lines 9-9 to reflect that a cuff electrode500 may exhibit at least some of substantially the same features andattributes as the cuff electrode 300 represented in the sectional viewof FIG. 9. Moreover, it will be understood that, in a manner similar tothat depicted in FIGS. 6A-6B (in which the cuff body releasably contactsa nerve 261) and/or FIGS. 7A-7K, the arrangements shown in FIGS. 12-13Balso may schematically represent a method of neurostimulation and/ortherapy to treat sleep disordered breathing, such as but not limited toobstructive sleep apnea. It will be understood that the nerve 261 isomitted in FIGS. 12-13B for illustrative clarity in such examples.

FIG. 14A is a sectional view schematically representing a cuff electrode600, according to one example of the present disclosure.

As shown in FIG. 14A, in at least some examples, cuff electrode 600comprises at least some of substantially the same features andattributes as the cuff electrode 100, 200 of FIGS. 1-6B and FIGS. 7A-7K.For instance, in some examples cuff electrode 600 may have a first array610 of electrodes 603A, 603B, 603C (e.g. first electrodes) extendingaxially like electrodes 103A, 103B, 103C (FIGS. 1-2) and a second array612 of electrodes 613A, 613B, 613C (e.g. second electrodes) extending ina circumferential orientation perpendicular to the axial orientationwith electrode 613B also acting as electrode 603B. Accordingly, in sucha configuration some portions (e.g. 252A, 254A, 252C, 254C in FIG. 5A)of a cuff body 601 omits electrodes and define cuff body portions freefrom electrically conductive elements.

However, unlike the configuration of electrodes 113A, 113B, 113C inFIGS. 1-6B, in the cuff electrode 600 of FIG. 14A two electrodes 613C,613A are included on a single arm (e.g. first arm 634) while the otherarm 650 omits any electrodes. Moreover, the third electrode 613B (sameas 103B) is located at or near base 620. In such a configuration, theelectrodes 613C, 613A are located away from the lead bodyattachment/spine, which in some examples may contribute to generallyequal circumferential spacing between the three inner electrodes 613C,613A, 613B. Other differences relative to the cuff electrode 100, 200 inFIGS. 1-6B are described further below and/or are observable from FIG.14A.

As further shown in FIG. 14A, the cuff body 601 comprises a first arm634 and a second arm 650. The first arm 634 has a proximal portion 635and an opposite distal portion 637 having distal end 636. The first arm634 also comprises an outer surface 638 and an inner surface 639, whichat least partially defines nerve-contact surface 641 of cuff body 601.The proximal portion 635 of first arm 634 extends from the base 620 andhas a thickness T1. In some examples, the first arm 634 has at least onesegment with a thickness which varies. In some such examples, the atleast one segment of varying thickness comprises at least one segment ofincreased thickness relative to other portions of the first arm 634. Insome examples, the at least one segment of varying thickness may beimplemented to house electrodes 613C, 613A. In some examples, the atleast one segment of first arm 634 having the varying thicknesscorresponds to an outer circumferential portion of a cuff body, such asportion 651C in FIG. 15A, portions 652C, 651C, 654C in FIGS. 15B, 15C,15D, portion 721B in FIG. 17A, and portions 722B, 721B, 724B in FIG.17B-17C.

In some examples, the at least one segment of first arm 634 exhibitingvarying thickness may be implemented as protrusions 615B, 615C which areoriented inwardly within the lumen 640C defined by the cuff body 601 andwhich partially define nerve-contact surface 641 of lumen 640C. In someinstances, these inwardly-oriented protrusions 615A, 615C may bereferred to as inward protrusions or internal protrusions. In someexamples, each inwardly-oriented protrusion 615A, 615C comprises agenerally convex shape, which stands in contrast to the generallyconcave shape of portions of the nerve-contact surface 641 other thaninwardly-oriented protrusions 615A, 615C. In some examples, at its apex,each protrusion 615A, 615C has a thickness T2, which is substantiallygreater than the thickness T1 of the non-protruding portions of thefirst arm 634. In some examples, T2 is at least two times T1. In somesuch examples, this increased thickness may ease molding of electrodes(e.g. 613C, 613A) into the arm 634 of the cuff body, and the cuff bodygenerally. In some examples, the protrusions 615A, 615C arecircumferentially spaced apart by a distance equal to the equalcircumferential spacing of electrodes 613A, 613B, 613C.

While FIG. 14A-14B depicts inwardly-oriented protrusions 615C, 615A, andwhile FIGS. 18A-18B depict outwardly-oriented protrusions, it will beunderstood that some examples may include similar protrusions in whichone or more such protrusions (housing electrodes 613C, 613A) may includeboth an inwardly-oriented portion and an outwardly-oriented portionand/or may include shapes other than those shown in FIGS. 14A-14B or18A-18B to provide a relatively increased thickness in an area of thearm to at least partially house electrodes.

Each protrusion 615C, 615A at least partially houses the respectiveelectrodes 613C, 613A. In some examples, each protrusion 615C, 615A hasa volume sufficient to securely retain each electrode 613C, 613A,associated hardware, and conductive lead wires that extend throughselect portions (e.g. inner axial portions (651C, 651B in FIG. 15A) ofcuff body 601. As shown in FIG. 14A, each protrusion 615C, 615A may beformed and/or shaped to expose at least a portion of the respectiveelectrodes 613C, 613A at the nerve-contact surface 641 of the cuff body601 to engage the nerve.

The electrodes 613C, 613A may be implemented in a variety of shapes,such as but not limited to the spherical shape shown in the sectionalview of FIG. 14A. For instance, the electrodes may have a cylindricalshape with an outer curved surface exposed at the nerve-contact surface641 of the lumen 640. In other instances, as shown later in FIG. 14B,electrodes 663C, 663A may have an arc shape which matches the generalcontour of the protrusions 665C, 665A.

In some examples, the inwardly-oriented protrusions 615C, 615A may causethe exposed electrode surface 618C, 618A to define a radius R2 relativeto center of lumen 640C that is less than a radius R1 of remainder ofnerve-contact surface 641 of the lumen. In some examples, R2 issubstantially less than R1. In some examples, the varying thickness andradius of the first arm 634 may sometimes be referred to as acircumferential profile of the nerve-contact surface 641 extending alongfirst arm 634.

In some examples, the inwardly-oriented protrusions in which theelectrodes are housed may enhance operable coupling of the electroderelative to one or more nerve groups within the nerve. For instance, inat least some examples, at least some branches/fibers within the nervemay adapt and flow around/about the respective protrusions, therebyresulting in the various nerve branches being in close proximity to therespective electrodes (within the respective protrusions) to establishgood connectivity between the nerve (branches) and the electrodes.

The second arm 650 comprises a proximal portion 655 and a distal portion622 with a distal end 656. The proximal portion 655 has a thickness T3while the distal portion 622 has a thickness T4. In some examples, anarc length of the distal portion 622 of second arm 650 overlaps asubstantial majority of the arc length of the first arm 634. In someexamples, the overlap corresponds to at least about 30 degrees of arclength.

In some examples, second arm 650 comprises a transition portion 669defining a transition between the proximal portion 655 and distalportion 622. In some examples, transition portion 669 includes a shelf670 defined by an end of proximal portion 655 of second arm 650 andincludes a proximal end 624 of distal portion 622 of second arm 650.

While generous spacing is shown in FIG. 14A between distal end 636 offirst arm 634 and the shelf 670 of second arm 650, it will be understoodthat it is intended that shelf 670 provides an area by which distal end636 of first arm 634 may make releasable contact with second arm 650.This arrangement limits the extent of rotational movement of first arm634, which may bolster structural integrity of cuff body 101 and alsodefines minimum diameter of lumen 640C so as to prevent undue pressureand/or constriction on a nerve.

Moreover, the greater thickness T3 of the proximal portion 655 of secondarm 650 provides additional structural strength to support releasablecontact from distal end 636 of first arm 634 and/or to maintain a shapeof lumen 640C.

In some examples, the shelf 670 has a width W generally the same as orwider than the width W of the distal end 636 of the first arm 634.

In addition to the shelf 670, the transition portion 669 includes thedistal portion 622 extending directly from the proximal portion 655. Insome examples, the distal portion 622 has a generally uniform thicknessT4 throughout its length. In some examples, the distal portion 622 ofthe second arm 650 has an inner surface 626 defining a generallyconstant radius of curvature while the outer surface 638 of the firstarm 634 has a generally constant radius of curvature that generallymatches the radius of curvature of the inner surface 626 of the distalportion 622 of the second arm 650. Via this arrangement, in itsoverlapping relation with the at least the first arm 634, the distalportion 622 of the second arm 650 lies generally flat against the firstarm 634. This arrangement may enhance the integrity and holding strengthof cuff body 601 relative to the nerve, while simultaneouslyaccommodating any temporary nerve swelling upon implantation and/oraccommodating different size nerves.

Each arm 634, 650 is shaped and formed of a resilient material such thatthe opposingly-oriented arms 634, 650 are biased into the configurationshown in FIG. 14A to remain in a releasably secured position about anerve. However, each arm 634, 650 has sufficient flexibility to permitbeing manipulation of the distal portion 622 of second arm 650 anddistal portion 637 of first arm 634 to enable opening cuff body 601 toreceive nerve within lumen 640C, and upon release of the respective arms634, 650, to return the cuff body 601 to the closed configuration shownin FIG. 14A.

In defining different circumferential portions and/or different axialportions of the cuff body 601 of FIG. 14A, it will be understood that incomparison to the example of FIGS. 1-6B, in some examples the first arm634 and the proximal portion 655 of the second arm 650 may be consideredanalogous to the first arm 134 and to the second arm 150, respectively.

FIG. 14B is sectional view schematically representing a cuff electrode660, according to one example of the present disclosure. In someexamples, the cuff electrode 660 (including cuff body 661) comprises atleast some of substantially the same features and attributes of cuffelectrode 600 of FIG. 14A (including cuff body 601), except for theinwardly-oriented protrusions 665C, 665A having a lower radial profile(i.e. less thickness) and the electrodes 663C, 663B, 663A having an arcshape instead of a spherical or cylindrical shape. In some examples, athickness T5 of each inwardly-oriented protrusion 665C, 665A has athickness T5 is substantially less than a thickness T2 of theinwardly-oriented protrusions 615C, 615A of the cuff electrode 600 inFIG. 14A. In some examples, the thickness T5 is no more than twice thethickness T1 of the proximal portion 635 of the first arm 634.

In some examples, the arc-shaped electrodes 663C, 663A comprise aconvex-shaped electrode contact surface 668C, 668A within lumen 640B forreleasably contacting a nerve. In some examples, the arc-shapedelectrode 663B comprises a concave-shaped electrode contact surface 668Bfor releasably contacting the nerve within lumen 640B.

It will be understood that in some examples, electrodes 663C, 663A mayhave shapes other than an arc-shape. For instance, the electrodes 663C,663A may be concave or even flat (e.g. not curved), or otherconvex-shaped, disc-shaped, etc. with adjacent portions of theprotrusion supporting the electrode shape in a complementary manner toyield a suitable nerve-electrode interface.

FIG. 15A is a diagram including a plan view schematically representing anerve-contact surface 641 and an electrode pattern associated with thecuff electrodes 600, 660 in FIGS. 14A-14B, according to one example ofthe present disclosure. In some examples, the cuff electrode 600 of FIG.15A comprises at least some of substantially the same features andattributes as cuff electrode 600 (FIG. 14A) and cuff electrode 660 (FIG.14B). For simplicity, further discussion regarding FIG. 15A will refersolely to cuff electrode 600 even though it will be applicable to bothcuff electrodes 600 (FIG. 14A), 660 (FIG. 14B).

In some examples, the cuff electrode 600 in FIG. 15A comprises differentcircumferential portions and axial portions of a cuff body 601 in thesubstantially the same manner as the different portions of the cuff body101, 201 for the cuff electrode in FIG. 3-5B. With this in mind, theinner circumferential portions 652B, 651B, 654B of cuff body 101 houseelectrodes 603A, 603B (same as 613B), 603C, respectively, while theouter circumferential portion 651C (also an inner axial portion) houseselectrodes 613A, 613C. In some examples, the outer circumferentialportion 651C generally corresponds to at least the distal portion 637 offirst arm 634 (FIG. 14A).

As shown in FIG. 15A, in some examples the circumferential array ofelectrodes 613B, 613A, 613C are equally spaced apart, as represented bydistances D1 and D2.

Meanwhile, the dashed lines 615A, 615C in FIG. 15A represent the innerprotrusions 615A, 615C (FIG. 14A) when the inner protrusions areimplemented as generally circular elements within portion 651C of cuffbody 601. In some such configurations, the generally circular elementsmay facilitate molding and/or retention of the electrodes within thecuff body.

However, in some examples, as shown in FIG. 15B, the inner protrusions615A, 615C are implemented as elongate elements represented by shadedregions 669A, 669C which may extend a length (L1) of the cuff body 601.In some such configurations, the elongate elements may facilitatemolding and/or retention of the electrodes within the cuff body, as wellas routing of wires within/through the cuff body.

FIG. 15C is a diagram including a plan view schematically representing anerve-contact surface of a cuff electrode 700 and electrode patternrelative to some circular-shaped, inwardly-oriented protrusions of anerve-contact surface, according to one example of the presentdisclosure. The cuff electrode 700 comprises at least some ofsubstantially the same features as cuff electrode 600 in FIG. 15A,except having electrodes 623A, 623C in portion 652C and electrodes 633A,633C in portion 654C with each of these electrodes housed in aninwardly-oriented protrusion 625A, 625C, 635A, 635C, respectively withinwardly-oriented protrusions 625A, 625C, 635A, 635C havingsubstantially the same features as inwardly-oriented protrusions 615A,615C (FIG. 14A) or 665A, 665C (FIG. 14B).

In some examples, the general electrode pattern in cuff electrode 700comprises at least some of substantially the same features andattributes as cuff electrode 300 in FIG. 8A-9, as least to the extentthat cuff electrode 700 comprises three axial arrays of electrodes andthe manner in which they may operate together or independently.

In some examples, as shown in FIG. 15D, the inwardly-orientedprotrusions housing the electrodes 623A, 623C (in portion 652C), 613A,613C (in portion 651C), 633A, 633C (in portion 654C) are implemented aselongate elements represented by shaded regions 669A, 669B in a mannersimilar to that shown in FIG. 15B.

It will be understood that, in a manner similar to that depicted inFIGS. 6A-6B (in which the cuff body releasably contacts a nerve 261)and/or FIGS. 7A-7K, the arrangements shown in FIGS. 14A-14B, 15A-15Calso may schematically represent a method of neurostimulation and/ortherapy to treat sleep disordered breathing, such as but not limited toobstructive sleep apnea. It will be understood that the nerve 261 isomitted in FIGS. 14A-14B, 15A-15C for illustrative clarity in suchexamples.

FIG. 16 is a diagram including an isometric view schematicallyrepresenting different portions of a cuff body 720 for a cuff electrodelike that of FIGS. 14A-14B, according to one example of the presentdisclosure. In some examples, the cuff body 720 comprises at least someof substantially the same features and attributes as the cuff body 101,201 (FIGS. 1-6B), except with cuff body apportioned as twocircumferential portions instead of as three (two outer, one inner)circumferential portions. Accordingly, in some examples, the cuff body720 includes a first circumferential portion 710 and a secondcircumferential portion 712. In some examples, the respective first andsecond circumferential portions 710, 712 may sometimes be referred to asfirst and second half portions or as an upper half portion 710 and lowerhalf portion 712. In some instances, the lower half portion 712 maysometimes be referred to as a lower circumferential portion while theupper half portion 710 may sometimes be referred to as an uppercircumferential portion.

In some examples, the lower half portion 712 has an arc length or widthW11, while the upper half portion 710 has an arc length or width W12,which is generally equal to W11.

Accordingly, as shown in FIG. 17A, electrodes 603A, 603B, 603C extendaxially with one electrode present in each of the portions 722A, 721A,724A of cuff body 720 while electrodes 613A, 613B, 613C extend in acircumferential orientation with both electrodes 613A, 613C residing inportion 721B. Portions 722B, 724B omit any electrodes. As representedvia the dashed lines 615A, 615C, each electrode 613A, 613C is housed ina circular-shaped inwardly-oriented protrusion in a manner as previouslydescribed in association with at least FIG. 15A, 15C to implementhousing an electrode via the inwardly-oriented protrusions as in FIG.14A or 14B.

In some examples, each of the upper circumferential, outer axial cuffbody portions 722B, 724B omit electrodes (and therefore are generallyelectrically conductive-free portions).

FIG. 17B is a diagram including a plan view schematically representing anerve-contact surface 641 of a cuff electrode 740 and electrode patternrelative to some circular-shaped inwardly-oriented protrusions of anerve-contact surface, according to one example of the presentdisclosure. The cuff electrode 740 comprises at least some ofsubstantially the same features as cuff electrode 700 in FIG. 15C,except for cuff body 741 apportioned as two circumferential portionsrather than thee circumferential portions (two outer, one inner) in FIG.15C. Accordingly, as shown in FIG. 17B, in cuff electrode 740 theportion 722B includes electrodes 623A, 623C while portion 724B includeselectrodes 633A, 633C. Each of these electrodes are housed in aninwardly-oriented protrusion 625A, 625C, 635A, 635C, respectively withinwardly-oriented protrusions 625A, 625C, 635A, 635C havingsubstantially the same features as inwardly-oriented protrusions 615A,615C (FIG. 14A) or 665A, 665C (FIG. 14B).

In some examples, the general electrode pattern in cuff electrode 740 inFIG. 17B comprises at least some of substantially the same features andattributes as cuff electrode 300 in FIG. 8A-9, as least to the extentthat cuff electrode 740 comprises three axial arrays of electrodes andthe manner in which they may operate together or independently.

In some examples, as shown in FIG. 17C, a cuff electrode 750 includesinwardly-oriented protrusions (to house the electrodes) implemented aselongate elements represented by shaded regions 669A, 669B in a mannersimilar to that shown in FIG. 15B.

With further reference to the example of FIG. 17C in which theinwardly-oriented protrusions are implemented as elongate elements (i.e.shaded regions 669A, 669C), additional electrodes 623A, 623C may beimplemented in portion 722B) and additional electrodes 633A, 633C may beimplemented in portion 724B. In such examples, the general electrodepattern in cuff electrode 750 in FIG. 17C comprises at least some ofsubstantially the same features and attributes as cuff electrode 300 inFIG. 8A-9, as least to the extent that cuff electrode 700 would comprisethree axial arrays of electrodes and the manner in which they mayoperate together or independently.

It will be understood that, in a manner similar to that depicted inFIGS. 6A-6B (in which the cuff body releasably contacts a nerve 261)and/or FIGS. 7A-7K, the arrangements shown in FIGS. 16-17C also mayschematically represent a method of neurostimulation and/or therapy totreat sleep disordered breathing, such as but not limited to obstructivesleep apnea. It will be understood that the nerve 261 is omitted inFIGS. 16-17C for illustrative clarity in such examples.

FIG. 18A is a sectional view schematically representing cuff electrode900, according to one example of the present disclosure. In someexamples, cuff electrode 900 comprises at least some of substantiallythe same features and attributes as cuff electrode 600, 660 in FIG.14A-14B, except for having outwardly-oriented protrusions 915C, 915A toat least partially house electrodes 913C, 913A instead of theinwardly-oriented protrusions 615C, 615A of the cuff electrode 600 inFIG. 14A-14B.

In some examples, the cuff electrode 900 has a second arm 950 likesecond arm 650 of cuff electrode 600 in FIG. 14A-14B, except with thesecond arm 950 having a proximal portion 955 with a thickness T7 greaterthan a thickness T3 (FIG. 14A) of proximal portion 655 of second arm 650of cuff body 601. In some examples, the greater thickness T7 is providedso that the inner surface of proximal portion 955 (of second arm 950)defining part of nerve-contact surface 941 will match and/or complementthe radius of the other portions of the nerve-contact surface 941 ofcuff body 901. This arrangement also positions the proximal portion 928of the distal portion 922 of second arm 950 to orient the contour of theinner surface 926 of the distal portion 922 to accommodate theoutwardly-oriented protrusions 915C, 915A in a manner such that the biasof the distal portion 922 will result in the distal portion 922 wrappingin a complementary relationship about the outer surface 938 (includingthe outward protrusions 915C, 915A) of the first arm 934.

As further shown in FIG. 18A, like in the example of FIG. 14A the firstarm 934 comprises a proximal portion 935 extending from a base 920A ofcuff electrode 900 and comprises an opposite distal portion 937 having adistal end 936. Moreover, the second arm 950 comprises a proximalportion 955 and an opposite distal portion 922 having distal end 956.

In contrast with the examples in FIGS. 14A-14B, in the presentarrangement of outwardly-oriented protrusions 915C, 915A, the extraspace involved in housing the electrodes 913C, 913A (and relatedconductive wires) is oriented outward away from the nerve-contactsurface 941. Via this arrangement the nerve-contact surface 941 of thecuff body 901 defined by lumen 940C maintains a generally uniform radiusof curvature such that the contact surface 918C, 918A of the electrodes913C, 913A are generally flush with other portions of the nerve-contactsurface 941 of the cuff body 901. Via this arrangement, thenerve-contact surface 941 of the cuff electrode 900 as a whole is highlycomplementary of the outer surface/circumference of the nerve to whichit is engaged.

FIG. 18B is a sectional view schematically representing a cuff electrode960, according to one example of the present disclosure. In someexamples, cuff electrode 960 comprises at least some of substantiallythe same features and attributes as cuff electrode 900 (FIG. 18A),except having arc-shaped electrodes 963C, 963A instead ofspherically-shaped or cylindrically-shaped electrodes 913C, 913A (FIG.18A). In some examples, a thickness T8 of the outward protrusions 965C,965A is less than a thickness T6 of the outward protrusions 915C, 915A(FIG. 18A) because of a lower radial profile of the arc-shapedelectrodes 963C, 963A. In some examples, the electrodes 963C, 963A haveconcave-shaped nerve-contact surfaces 968C, 968A which are generallyflush with the nerve-contact surface 941 of the cuff body 961. Via thisarrangement, while the outwardly-oriented protrusions 965C, 965Aaccommodate the volume of the electrodes 963C, 963A and connectedconductive lead wires (and associated connection structures), thenerve-contact surface 941 of the cuff body 961 retains a generallyuniform radius which may facilitate close engagement relative to thenerve.

As further shown in FIG. 18B, like in the example of FIG. 18A the firstarm 934 comprises a proximal portion 935 extending from a base 920B ofcuff electrode 960 and comprises an opposite distal portion 937 having adistal end 936. Moreover, the second arm 950 comprises a proximalportion 955 and an opposite distal portion 922 having distal end 956. Asfurther shown in FIG. 18B, in some examples, the arc-shaped electrodes963C, 963B, 963A comprise a concave-shaped electrode contact surface968C, 968B, 968A of nerve-contact surface 941 within lumen 940C forreleasably contacting a nerve.

In some examples, the respective cuff electrode 900 and 960 of FIGS.18A, 18B may comprise any one of (or combinations of) the variouselectrode configurations and/or cuff body configurations as previouslydescribed in association with FIGS. 15A-15D, 16, 17A-17C, except forbeing implemented with outwardly-oriented protrusions (915C, 915A, 965C,965A in FIGS. 18A, 18B) instead of with inwardly-oriented protrusions(615C, 615A, 665C, 665A in FIGS. 14A, 14B).

In some examples, the electrodes 613C, 613B, 613A (FIG. 14A), electrodes663C, 663B, 663A (FIG. 14B), electrodes 913C, 913B, 913A (FIG. 18A),and/or electrodes 963C, 963B, 963A (FIG. 18B) may be implemented withina cuff body of a cuff electrode having at least some of substantiallythe same features and attributes as one of the cuff electrodes describedin Bonde et al. U.S. Pat. No. 9,227,053, “Self-Expanding ElectrodeCuff”, issued on Jan. 5, 2016, and in Bonde et al. U.S. Pat. No.8,340,785, “Self-Expanding Electrode Cuff”, issued on Dec. 25, 2012,both of which are herein incorporated by reference.

In some examples, an implantable pulse generator (IPG) 1110 (FIG. 19A,19B) forms part of a system including the cuff electrode 900, 960 and inwhich at least one electrode(s) may be located on a housing of the pulsegenerator IPG 1110.

It will be understood that, in a manner similar to that depicted inFIGS. 6A-6B (in which the cuff body releasably contacts a nerve 261)and/or FIGS. 7A-7K, the arrangements shown in FIGS. 18A, 18B also may beunderstood as schematically representing a method of neurostimulationand/or therapy to treat sleep disordered breathing, such as but notlimited to obstructive sleep apnea, with nerve 261 omitted from FIGS.18A-18B for illustrative clarity in such examples.

FIG. 19A is a block diagram schematically representing aneurostimulation system 1100, according to one example of the presentdisclosure. System 1100 comprises a pulse generator 1110, lead body1102, and cuff electrode 1104 supported by the lead body 1102. In someexamples, the cuff electrode 1104 comprises any one of the cuffelectrodes as described in association with at least FIGS. 1-18B, FIGS.24-27, and/or combinations of some features of such cuff electrodes. Insome examples, neurostimulation system 1100 comprises a totallyimplantable system.

FIG. 19B is a block diagram schematically representing aneurostimulation system 1150, according to one example of the presentdisclosure. System 1150 comprises a pulse generator 1110 and a leadlesscuff electrode 1154. In some examples, the cuff electrode 1154 comprisesany one of the cuff electrodes as described in association with at leastFIGS. 1-18B, FIGS. 24-27, and/or combinations of some features of suchcuff electrodes. In some examples, neurostimulation system 1150comprises a totally implantable system. However, in some examples, thepulse generator 1110 or a portion of the pulse generator 1110 is locatedexternal to the patient. The cuff electrode 1154 is in wirelesscommunication with the pulse generator 1110 and/or related components tomanage therapy, including applying electrical stimulation. Accordingly,in some examples the cuff electrode 1154 includes and/or is associatedwith an antenna and related circuitry to implement such wirelesscommunication.

FIG. 20 is a block diagram schematically representing a control portion1700, according to one example of the present disclosure. In someexamples, control portion 1700 includes a controller 1702 and a memory1704. In some examples, control portion 1700 provides one exampleimplementation of a control portion forming a part of and/orimplementing the implantable medical devices and methods as representedthroughout the present disclosure in association with FIGS. 1-29B.

In general terms, controller 1702 of control portion 1700 comprises atleast one processor 1703 and associated memories. The controller 1702 iselectrically couplable to, and in communication with, memory 1704 togenerate control signals to direct operation of at least some componentsof the devices, elements, components, functions, methods, etc. describedthroughout the present disclosure. In some examples, these generatedcontrol signals include, but are not limited to, employing manager 1705stored in memory 1704 to manage therapy for sleep disordered breathing,including but not limited to applying nerve stimulation, in the mannerdescribed in at least some examples of the present disclosure. In someexamples, such generated control signals may at least partially controlselective stimulation via the different electrodes on a cuff electrode.It will be further understood that control portion 1700 (or anothercontrol portion) may also be employed to operate general functions ofthe various devices and/or components thereof described throughout thevarious examples of the present disclosure.

In response to or based upon commands received via a user interface(e.g. user interface 1710 in FIG. 21) and/or via machine readableinstructions, controller 1702 generates control signals to implementtherapy (including but not limited to nerve stimulation) and/orcircuitry control in accordance with at least some of the previouslydescribed examples of the present disclosure. In some examples,controller 1702 is embodied in a general purpose computing device whilein some examples, controller 1702 is incorporated into or associatedwith at least some of the associated components of the devices asdescribed throughout the present disclosure.

For purposes of this application, in reference to the controller 1702,the term “processor” shall mean a presently developed or futuredeveloped processor (or processing resources) that executes sequences ofmachine readable instructions contained in a memory. In some examples,execution of the sequences of machine readable instructions, such asthose provided via memory 1704 of control portion 1700 cause theprocessor to perform actions, such as operating controller 1702 toimplement sleep disordered breathing (SDB) therapy (including but notlimited to nerve stimulation), as generally described in (or consistentwith) at least some examples of the present disclosure. The machinereadable instructions may be loaded in a random access memory (RAM) forexecution by the processor from their stored location in a read onlymemory (ROM), a mass storage device, or some other persistent storage(e.g., non-transitory tangible medium or non-volatile tangible medium,as represented by memory 1704. In some examples, memory 1704 comprises acomputer readable tangible medium providing non-volatile storage of themachine readable instructions executable by a process of controller1702. In some examples, hard wired circuitry may be used in place of orin combination with machine readable instructions to implement thefunctions described. For example, controller 1702 may be embodied aspart of at least one application-specific integrated circuit (ASIC). Inat least some examples, the controller 1702 is not limited to anyspecific combination of hardware circuitry and machine readableinstructions, nor limited to any particular source for the machinereadable instructions executed by the controller 1702.

FIG. 21 is a block diagram schematically representing user interface1710, according to one example of the present disclosure. In someexamples, user interface 1710 forms part or and/or is accessible via adevice external to the patient and by which the implantable medicaldevice (or portions thereof) may be at least partially controlled and/ormonitored.

In some examples, user interface 1710 comprises a user interface orother display that provides for the simultaneous display, activation,and/or operation of features and attributes of an implantable medicaldevice. In some examples, at least some portions or aspects of the userinterface 1710 are provided via a graphical user interface (GUI). Insome examples, as shown in FIG. 21, user interface 1710 includes display1712 and input 1714.

FIG. 22A is flow diagram schematically representing an example method2000 of selective stimulation. As shown in FIG. 22A, in some examplesmethod 2000 comprises arranging at least three inner electrodescircumferentially spaced apart about a cuff body (at 2010) andselectively stimulating at least one nerve branch within a nerve via asubset of the three inner electrodes in combination with two outerelectrodes axially spaced apart from the inner electrodes (at 2012). Insome examples, one or more of the inner electrodes may serve as an anodewhile the outer electrodes may serve as a cathode(s) to provide aguarded cathode arrangement.

In some examples, method 2000 may be implemented via at least some ofsubstantially the same features and attributes as any one of (or acombination of) the devices, cuff electrodes, cuff bodies, electrodeconfigurations, etc. as described in association with at least FIGS.1-21 and/or 24-29B.

In addition, various additional aspects of method 2000 are presentedbelow.

As shown in FIG. 22B at 2020, in some examples method 2000 may furthercomprise arranging a second array of at least two outer electrodesaxially along a first orientation perpendicular to the secondorientation and on respectively opposite ends of the first array, witheach respective outer electrode spaced axially apart from the firstarray.

As shown at 2025 in FIG. 22C, in some examples method 2000 may furthercomprise selectively stimulating at least the first nerve branch withtwo electrodes of the first array while generally excluding a secondnerve branch from stimulation.

As shown at 2030 in FIG. 22D, in some examples method 2000 may furthercomprise at least one of not activating a third electrode of the firstarray and activating the third electrode of the first array toselectively at least partially hyperpolarize the second nerve branch.

As shown at 2035 in FIG. 22E, in some examples method 2000 may furthercomprise selectively stimulating at least the first nerve branch viaselectively stimulating the first nerve branch via a first electrode ofthe first array and separately selectively stimulating a third nervebranch via an adjacent second electrode of the first array.

As shown at 2040 in FIG. 22F, in some examples method 2000 may furthercomprise arranging the second array to comprise at least threeelectrodes, including the at least two outer electrodes, arrangedaxially along the first orientation and further comprising arranging aninner electrode axially between the at least two outer electrodes. Insome such examples, the method 2000 further comprises arranging theinner electrode of the second array to also define one of the electrodesof the first array.

FIG. 22G is flow diagram schematically representing an example method2100 of selective stimulation. As shown in FIG. 22G, in some examplesmethod 2100 comprises arranging at least one array of first electrodesto extend axially on a cuff body in a first orientation along a lengthof a nerve (at 2110) and arranging a second array of second electrodesto extend circumferentially on the cuff body in a second orientationgenerally perpendicular to the first orientation (at 2120).

In some examples method 2100 may further comprise arranging the firstelectrodes to include an inner electrode and two outer electrodes onopposite ends of the inner electrode. In some such examples, one of thefirst electrodes selectively functions as one of the second electrodes.In some such examples, the three electrodes may be equally spaced apart.

As shown at 2140 in FIG. 22H, in some examples method 2100 may furthercomprise selectively stimulating at least a first nerve branch viaselectively activating at least one second electrode in combination withselective activation with at least some of the first electrodes. In somesuch examples, the method 2100 at 2140 may comprise performing theselective activation via at least two second electrodes.

In some such examples, the method 2100 at 2110, 2120 may compriseselectively stimulating at least a first nerve branch via selectivelyactivating at least some of the second electrodes without activating thefirst electrodes.

As shown at 2150 in FIG. 22I, in some examples method 2100 may furthercomprise arranging the cuff body to include an inner axial portion andtwo outer axial portions on opposite ends of the inner axial portion. Insome such examples method 2100 may further comprise arranging the cuffbody such that each respective axial portion includes an innercircumferential portion and two outer circumferential portions onopposite ends of the inner circumferential portion, as shown at 2155 inFIG. 22J.

Moreover, in some such examples, as shown at 2160 in FIG. 22K, method2100 may further comprise arranging the outer circumferential portionsto be shaped, and biased for releasable engagement of the outercircumferential portions relative to each other to define a reclosablelumen to encircle a nerve. In some such examples, method 2100 maycomprise arranging the cuff body to form at least a 270 degreecircumferential structure, which extends a full length of the cuff body.In some such examples, the cuff body may form an at least 360 degreecircumferential structure.

With further reference to at least box 2150 in FIG. 22I, as shown at2170 in FIG. 22L, method 2100 may further comprise arranging arespective one of the first electrodes to be in each of the respectiveinner and outer axial portions. As shown at 2175 in FIG. 22M, in somesuch examples method 2100 may further comprise arranging the outercircumferential portions of each respective outer axial portion of thecuff body to be electrode-free. Moreover, in some such examples (such asat at least 2175), method 2100 may further comprise arranging the secondelectrodes to be located in at least one of the respective outercircumferential portions of the inner axial portion of the cuff body, asshown at 2180 in FIG. 22N.

In some such examples (such as at at least 2180), method 2100 mayfurther comprise arranging the second electrodes comprises arranging twosecond electrodes on one outer circumferential portion of the inneraxial portion, as shown at 2185 in FIG. 22O. In some such examples (suchas at at least 2185), method 2100 may further comprise arranging theother respective outer circumferential portion to be electrode-free, asshown at 2190 in FIG. 22P. In some such examples (such as at at least2190), method 2100 may further comprise arranging a stimulation signalvector to include one second electrode in an outer circumferentialportion of the inner axial portion and the outer first electrode in eachrespective outer axial portion of the cuff body, as shown at 2195 inFIG. 22Q.

In some examples in which the second electrodes are to be located in atleast one of the respective outer circumferential portions of the inneraxial portion of the cuff body, some examples of method 2100 may furthercomprise arranging at least three second electrodes on one outercircumferential portion of the inner axial portion, as shown at 2200 inFIG. 22R. In some such examples, method 2100 may further comprisearranging the one outer circumferential portion to include at least oneincreased thickness portion to house the second electrode(s) and exposea portion of the second electrode within the lumen defined by the cuffbody, as shown at 2210 in FIG. 22S.

In some such examples (such as at at least 2210), method 2100 mayfurther comprise arranging the two second electrodes and an inner axialelectrode to be equally spaced apart circumferentially, in the secondorientation, about the contact surface of cuff body, as shown at 2220 inFIG. 22T. In some such examples (such as at 2220), method 2100 mayfurther comprise arranging the at least one increased thickness portionto be oriented inwardly toward the nerve (e.g. FIGS. 14A, 14B, other).In some such examples (such as at 2220), method 2100 may furthercomprise arranging the at least one increased thickness portion to beoriented outwardly away from the nerve (e.g. FIGS. 18A, 18B, other).

With further reference to at least box 2150 in FIG. 22I, method 2100 mayfurther comprise arranging one second electrode to be located on oneouter circumferential portion in the inner axial portion of the cuffbody and the other second electrode on the other respective outercircumferential portion in the inner axial portion of the cuff body, asshown at 2230 in FIG. 22U.

In some examples, the example method(s) (e.g. 2100, etc.) described inassociation with FIGS. 22G-22U may be implemented via at least some ofsubstantially the same features and attributes as any one of (or acombination of) the devices, cuff electrodes, cuff bodies, electrodeconfigurations, arrangements, methods, etc. as described in associationwith at least FIGS. 1-22F and/or 24-29B.

FIGS. 23-28 relate to several example cuff electrodes and/or associatedmethods including a distal extension for applying selective stimulationto at least some example nerve branch configurations. With this in mind,FIG. 23 is a diagram 3000 schematically representing an example nervebranch configuration 3010 at which an example cuff electrode may bemounted, such as at least some of the example cuff electrodes describedin association with at least FIGS. 24-27. As shown in FIG. 23, nervebranch configuration 3010 comprises a main nerve 3011 from which variousbranches may diverge as the main nerve 3011 progresses distally. In someexamples, nerve branch configuration 3010 may comprise a main branch3020 (e.g. a protrusor branch) and one or more side branches, such asbranch 3024 and/or branch 3032. In the particular example configuration3010 shown in FIG. 23, branch 3024 corresponds to a retractor-relatedbranch, which innervates a muscle to cause retraction of the tongue andbranch 3022 causes neither protrusion nor retraction of the tongue, butmay cause some deviation (3032) of the tongue from a resting position.As further shown in FIG. 23, branch 3024 and main branch 3020 may form ajunction 3042 while branch 3020 and branch 3022 may form a junction3044.

In examples in which one may desire to stimulate solely the main branch3020, one desired placement of a cuff electrode (as represented by arrow3040) may be distal of the dashed line 3050 such that the cuff electrodemay solely engage the main branch 3020. However, in many instances, sucha placement is not feasible because of the close proximity of thediverging branches 3032, 3024, surrounding non-nerve structures, etc.Accordingly, in some instances, at least one of the example cuffelectrodes described below may enable securing the cuff electrode atsite A (3052) while still positioning a distal extension of the cuffelectrode in a position adjacent the main branch 3020 to stimulatesolely (or primarily) the main branch 3020 to cause protrusion of thetongue without otherwise stimulating other deviation-causing nervebranches 3022, 3024.

It will be understood that the example nerve configuration shown in FIG.23 is just one example and that other nerve configurations may bepresent, with the example devices and methods in FIGS. 24-27 beingapplicable for at least some alternate nerve configurations.

FIG. 24 is a diagram 4000 schematically representing an example cuffelectrode 4100 including a distal extension 4150 engaged relative to anexample nerve branch configuration 4010. In some examples, example nervebranch configuration 4010 may comprise at least some of substantiallythe same features and attributes as example nerve branch configuration3010 in FIG. 23.

In some examples, at least the cuff body 4101 (and cuff electrodegenerally) comprises at least some of substantially the same featuresand attributes of the cuff electrodes as previously described inassociation with FIGS. 1-18B.

As shown in FIG. 24, example implantable lead assembly 4060 includes anexample cuff electrode 4100 releasably engaged about a main nerve 4010in which the cuff electrode 4100 encircles the sides 4011A, 4011B ofnerve 4010 and a spine 4120 of the cuff body 4101 extends generallyparallel to the nerve 4010. The cuff body 4101 includes a main bodyextending between a proximal end 4112B and a distal end 4112A, with adistal extension 4150 extending distally from distal end 4112A. Thedistal extension 4150 may be formed of the same or similar material ascuff body 4101 in some examples, and comprises opposite sides 4152A,4152B with distal end 4154. In some such examples, cuff electrode 4100may extend from lead 4070 or other lead.

As further shown in FIG. 24, in some examples cuff electrode 4100comprises an electrode array 4200 including multiple electrodes 4222,4224, 4226. It will be understood that array 4200 may include a greaternumber or fewer number of electrodes than shown in FIG. 24, which may bedistributed in patterns other than shown in FIG. 24. In the exampleshown in FIG. 24, one electrode 4222 may be located at or near a distalend 4112A of the main cuff body 4101 while the other two electrodes4224, 4226 may be located on distal extension 4150, such as near distalend 4154. In the example array 4200 shown, the electrodes 4224 and 4226are spaced apart laterally from each other such that one electrode 4224is locatable adjacent first nerve branch 4020 and the other electrode4226 is locatable adjacent second nerve branch 4022. In some examples,the first nerve branch 4020 corresponds to a nerve to be targeted forstimulation while the second nerve branch 4022 corresponds to a nervebranch to be excluded from stimulation, or at least not targeted forstimulation. In some examples, by utilizing a stimulation vector (V)between electrodes 4222 and 4224, the first nerve branch 4020 can becaptured and stimulated while excluding stimulation of second nervebranch 4022. In some examples, the first nerve branch 4020 maycorrespond to a tongue protrusor nerve branch and the second nervebranch 4022 may correspond to a tongue retractor nerve branch or othernerve branch.

Among other features, via this electrode configuration distributed onthe distal body extension 4150 and the main cuff body 4101, a specificnerve branch may be targeted for selective stimulation while stillsecuring the cuff electrode 4100 in general on a main nerve 4010proximal to the junction 4023 between the respective first and secondnerve branches 4020, 4022. This avoids the complication of attempting tosecure cuff body 4101 solely about first nerve branch 4020 andsimplifies number and position of electrodes 4224, 4222 used toimplement such stimulation.

In some examples, the main cuff body 4101 may omit any other electrodesbesides electrode 4222. In some such examples, the main cuff body 4101primarily acts to secure the cuff 4100 relative to the nerve while thedistal extension 4150 carrying electrodes 4224, 4226 primarily acts asthe active electrode portion of the cuff electrode 4100.

However, in some examples, in addition to the electrode 4222 (and theelectrodes 4224, 4226 on distal extension 4150), the main cuff body 4101may comprise at least some of substantially the same features andattributes of any one (or a combination of) of the example electrodeconfigurations previously described in association with at least FIGS.1-18B. In some such examples, at least some electrodes of the electrodearray 4200 (of distal extension 4150) may be activated in acomplementary manner with other electrodes of the main cuff body 4101.

As further illustrated in association with FIGS. 25-27, at least somemore specific or alternate examples of a distal extension of an examplecuff electrode 4100 may be positionable to be adjacent a nerve branch(e.g. 4020, 4022) without encircling the nerve branch (e.g. FIG. 25)and/or may be positionable to at least partially wrap about (e.g.encircle) the nerve branch (e.g. FIGS. 26, 27).

As apparent from the foregoing description associated with FIG. 24, itwill be understood that FIG. 24 also may be viewed as schematicallyrepresenting at least an example method of neurostimulation and/ortherapy for treating sleep disordered breathing, such as but not limitedto obstructive sleep apnea. In some examples, this arrangement and/ormethod may be employed other for treating bodily conditions and/or forother nerve structures.

FIG. 25 is a diagram 4500 schematically representing an example cuffelectrode 4560 including a distal extension 4650, which in some examplesmay comprise at least some of substantially the same features andattributes as example cuff electrode 4100 including distal extension4150 and/or the associated method of neurostimulation and/or therapy. Asshown in FIG. 25, the cuff electrode 4560 comprises a main cuff portion4600. In some examples, the main cuff portion 4600 comprises at leastsome of substantially the same features and attributes as the cuff body101 (e.g., at least FIGS. 1-4), where similar reference numerals mayrefer to similar elements. For instance, main cuff portion 4600 maycomprise opposing arms 4634, 4650 (like 134, 150) which are shaped andbiased to define a lumen 4640 (like lumen 140) and which have ends inreleasably contact at point 4609. The main cuff portion 4600 extendsbetween a proximal end 4607 and distal end 4608. The main cuff body 4601comprises and/or is supported by a base (e.g. 120 in FIG. 1), which inturn is supported by an elongate, resilient lead (not shown in FIG. 26).

As further shown in FIG. 25, distal extension 4650 extends from distalend 4608 of main cuff body 4601. In some examples, distal extension 4650comprises an elongate generally rectangular element having a proximalend 4651A and opposite distal end 4651B, and opposite sides 4652A,4652B.

The distal extension 4650 carries an array 4680 of electrodes 4682,4684, 4686, which are distributed about a surface of the distalextension 4650. Via such configurations, one electrode 4684 may be at adistal end 4615B, while another electrode (e.g. 4682 or 4686) may bespaced proximally therefrom. In some examples, at least a pair ofelectrodes 4682, 4686 may be spaced apart laterally, such as being on ornear opposite sides 4652A, 4652B of the distal extension 4650. Via atleast some such example configurations, a given electrode may belocatable adjacent a target nerve branch or a non-target nerve branch(e.g. a branch to be excluded from stimulation or at which stimulationis inhibited). In some examples, just one electrode is carried on thedistal extension 4650.

It will be understood that size, shape, and/or pattern of electrodes4682, 4684, 4686 in FIG. 25 is merely one example, and that theelectrodes 4682, 4684, 4686 may have different sizes, shape, and/orpatterns than shown in FIG. 26. In addition, in some examples, the array4680 may comprise a greater number or a fewer number of electrodes thanshown in FIG. 25. Moreover, in some examples, the electrodes (e.g. 4682,4684, 4686) on distal extension 4650 may comprise all of the electrodesfor the entire cuff electrode 4560.

However, in some examples, the main cuff portion 4600 may comprise atleast one electrode at its distal end 4608, similar to electrode 4222 inelectrode array 4200 as shown in FIG. 24. Moreover, in some examples,the main cuff portion 4600 may comprise several electrodes, some ofwhich may correspond to one of the example electrode configurationspreviously described in association with at least FIGS. 1-18B.

FIG. 26 is a diagram schematically representing an example cuffelectrode 4800 including a distal extension 4850. In some examples, thecuff electrode 4800 may comprise at least some of substantially the samefeatures and attributes as example cuff electrode 4100 including distalextension 4150 (FIG. 24) and/or main cuff portion 4600 (FIG. 25) and/orthe associated method of neurostimulation and/or therapy. In someexamples, example cuff electrode 4800 may comprise at least some ofsubstantially the same features and attributes as example cuff electrode4560 (FIG. 25), except having a distal extension 4850 having a differentshape, size, etc. than distal extension 4650 in FIG. 25. As shown inFIG. 26, distal extension 4850 may comprise a helical coil body 4852made of a resilient material biased to be at least partiallyself-wrappable about a first nerve branch (e.g. 4020 or 4022), withoutencircling the main nerve from which the first nerve branch extends.

The distal extension 4850 comprises a distal end 4851B and an oppositeproximal end 4851A, which extends from the distal end 4608 of the maincuff portion 4600. An array 4880 of electrodes 4882, 4884, 4886 isdistributed along various portions of the helical coil body 4852. Asnoted above, the electrodes 4882, 4884, 4886 may have a size, shape,position, and/or pattern different from shown in FIG. 26, and a greaternumber or fewer number of electrodes may comprise the array 4880.

In some examples, at least one of the electrodes 4882, 4884, 4886 ispositioned on the coil body 4852 to be locatable adjacent a first nervebranch (e.g. 4020) targeted for stimulation. In some examples, at leastone of the other/remaining electrodes 4882, 4884, 4886 is positioned onthe helical coil body 4852 to be locatable adjacent a second nervebranch (e.g. 4022) to inhibit stimulation of the second nerve branch(e.g. via hyperpolarization). In some examples, the two differentbranches may be selective stimulated via some combination of theelectrodes 4882, 4884, 4886 with or without inclusion of at least oneelectrode from main cuff portion 4600. With this in mind, in someexamples the main cuff portion 4600 may omit electrodes while in someexamples the main cuff portion 4600 may include at least some electrodesfor stimulation, such as but not limited to any one of (or a combinationof) the electrode configurations previously described in associationwith at least FIGS. 1-18B.

FIG. 27 is a diagram 5000 schematically representing an example cuffelectrode 5010 including a distal extension 5050. In some examples, thecuff electrode 5010 may comprise at least some of substantially the samefeatures and attributes as example cuff electrode 4100 including distalextension 4150 (FIG. 24) and/or the associated method ofneurostimulation and/or therapy, and/or as example main cuff portion4600 (FIG. 25). In some examples, cuff electrode 5010 may comprise atleast some of substantially the same features and attributes as examplecuff electrode 4560 (FIG. 25), except having a distal extension 5050having a different shape, size, etc. than distal extension 4650 in FIG.25. As shown in FIG. 27, distal extension 5050 may comprise acylindrically-shaped body 5052 made of a resilient material biased to beat least partially self-wrappable about a nerve branch, such as first orsecond nerve branch 4020 or 4022, without encircling the main nerve fromwhich the first nerve branch extends. In one aspect, body 5052 defines alumen (as represented via dashed lines 5053) through one of the nervebranches (e.g. 4020, 4022) may extend.

The distal extension 5050 comprises a distal end 5051B and an oppositeproximal end 5051A, which extends from the distal end 4608 of the maincuff portion 4600. The body 5052 may comprise a cuff body like main cuffbody 4601 or another type of cuff body having arms or other elementsbiased to selectively wrap about a nerve branch. In some examples, aninterior surface of the body 5052 (e.g. lumen 5053) may carry an arrayof electrodes distributed along various portions of the coil body 5052such that at least one of such electrodes may be locatable adjacent afirst nerve branch (e.g. 4020) targeted for stimulation. The array ofelectrodes may be arranged in a pattern as shown in FIG. 24, 25, or 26or may be arranged in a different pattern.

In some examples, at least one other/remaining electrodes may bepositioned on an exterior of body 5052 to be locatable adjacent a secondnerve branch (e.g. 4022) to stimulate or to inhibit stimulation of thesecond nerve branch. In some examples, the two different branches (e.g.4020, 4022) may be selectively stimulated via some combination of theelectrodes of distal extension 5050 with or without inclusion of atleast one electrode from main cuff portion 4600. With this in mind, insome examples the main cuff portion 4600 may omit electrodes while insome examples the main cuff portion 4600 may include at least someelectrodes for stimulation, such as but not limited to any one of (or acombination of) the electrode configurations previously described inassociation with at least FIGS. 1-18B.

FIG. 28A is flow diagram schematically representing an example method5500 of selective stimulation. As shown in FIG. 28A, in some examplesmethod 5500 comprises arranging at least two electrodes spaced apart ona distal extension, which extends from a main cuff body (at 5510),encircling a main nerve with the main cuff body while positioning thedistal extension to be located adjacent a first nerve branch (of themain nerve) apart from other diverging nerve branches (at 5512), andselectively stimulating the first nerve branch via at least one of thetwo electrodes of the distal extension in combination with anotherelectrode (at 5514).

As shown at 5530 in FIG. 28B, method 5500 may further compriseperforming the selective stimulation in combination with anotherelectrode supported by the distal extension and/or the main cuff body.In some examples, the distal extension may carry just one electrode.

In some examples, method 5500 may be implemented via at least some ofsubstantially the same features and attributes as any one of (or acombination of) the devices, cuff electrodes, cuff bodies, electrodeconfigurations, etc. as described in association with at least FIGS.24-27 and/or FIGS. 1-22.

As shown at 5535 in FIG. 28C, in some examples method 5500 may furthercomprise utilizing at least some electrodes of a main cuff body tostimulate a main nerve in a complementary manner with stimulating aparticular nerve branch via at least one of the electrodes of the distalextension.

However, in some examples the electrodes of the main cuff body do notcontribute to stimulating the main nerve and/or the main cuff body omitsany electrodes (i.e. the main cuff body is electrode-free). Accordingly,in some such examples the main cuff body may primarily act to secure theoverall cuff electrode relative to the main nerve, also thereby at leastpartially securing or supporting the distal extension relative to nervebranches distal to the main cuff body (and the main nerve).

In some examples, the main cuff body may comprise at least one electrodeat its distal end (e.g. 4608 such as in FIG. 24) to enable stimulationin cooperation with at least one electrode on a distal extension fromthe main cuff body.

As shown at 5540 in FIG. 28D, in some examples method 5500 may furthercomprise arranging the distal extension to be at least partiallyself-wrappable about the first nerve branch without encircling the mainnerve. In some such examples, the method may comprise arranging thedistal extension as at least one of a helical coil body (e.g. FIG. 26)and a cylindrically-shaped body (e.g. FIG. 27).

As shown at 5550 in FIG. 28E, in some examples method 5500 may furthercomprise arranging the distal extension to extend along a portion of thefirst nerve branch without at least partially wrapping about the firstnerve branch. In some such examples, method 5500 may further comprisearranging the distal extension as an elongate rectangular element (e.g.FIG. 24 or 25).

As shown at 5610 in FIG. 29A, in some examples method 5500 may beimplemented as a method 5600 comprising arranging a single firstelectrode on a distal extension, which extends from a main cuff body. At5615, method 5600 comprises encircling a main nerve with the main cuffbody while positioning the distal extension to be located adjacent afirst nerve branch of a main nerve. As shown at 5620, method 5600comprises selectively stimulating the first nerve branch solely via thesingle first electrode of the distal extension in association with atleast a second electrode. As shown at 5640 in FIG. 29B, in some examplesmethod 5600 may further comprise arranging the second electrode to be onthe main cuff body. In one aspect, in some such examples the first nervebranch extends separately and distally from proximal portions of themain nerve in which the first nerve branch is enclosed within the mainnerve.

Although specific examples have been illustrated and described herein,it will be appreciated by those of ordinary skill in the art that avariety of alternate and/or equivalent implementations may besubstituted for the specific examples shown and described withoutdeparting from the scope of the present disclosure. This application isintended to cover any adaptations or variations of the specific examplesdiscussed herein.

What is claimed is:
 1. A cuff electrode comprising: a main cuff body including a first arm, a second arm and a base; wherein the first and second arms extend circumferentially in opposite directions from the base to form a re-closable lumen to encircle a nerve, the lumen being open at opposing, proximal and distal ends of the cuff body; a distal extension extending from the cuff body distal the distal end; and a first electrode carried by the distal extension.
 2. The cuff electrode of claim 1, wherein the main cuff body is configured to releasably encircle a nerve.
 3. The cuff electrode of claim 1, wherein the distal extension is configured to locate the at least one electrode away from a location of a nerve about which the main cuff body encircles.
 4. The cuff electrode of claim 1, further comprising a second electrode carried by the distal extension.
 5. The cuff electrode of claim 1, wherein the distal extension defines a front side opposite a back side, further wherein the first electrode is exposed at the front side.
 6. The cuff electrode of claim 1, wherein the distal extension defines a front side opposite a back side, and further wherein the first electrode is exposed at the back side.
 7. The cuff electrode of claim 6, further comprising a second electrode carried by the distal extension and exposed at the front side.
 8. The cuff electrode of claim 1, wherein the distal extension comprises an elongate rectangular element.
 9. The cuff electrode of claim 1, wherein the distal extension comprises a helical coil body.
 10. The cuff electrode of claim 1, wherein the distal extension comprises a cylindrically-shaped body, and further wherein the first electrode is positioned on an exterior of the cylindrically-shaped body.
 11. The cuff electrode of claim 1, further comprising a second electrode carried by the main cuff body.
 12. A device comprising: a cuff electrode including: a main cuff body including a first arm, a second arm and a base, wherein the first and second arms extend circumferentially in opposite directions from the base to form a re-closable lumen to encircle a nerve, the lumen being open at proximal and distal ends of the cuff body, a distal extension extending from the cuff body distal the distal end, and a first electrode carried by the distal extension; a lead body extending from the base in a direction opposite the distal extension.
 13. A method comprising: encircling a nerve of a patient with a main cuff body of a cuff electrode at a first location of the nerve, the cuff electrode further including a distal extension extending distally from a distal end of the main cuff body; arranging the distal extension to position a first electrode carried by the distal extension away from the first location; and providing neurostimulation therapy to the patient via the cuff electrode.
 14. The method of claim 13, wherein the main cuff body carries a second electrode, and further wherein the step of providing neurostimulation therapy includes applying stimulation energy to the patient via at least the second electrode.
 15. The method of claim 14, wherein the step of providing neurostimulation therapy further includes applying stimulation therapy to the patient via the first electrode.
 16. The method of claim 15, wherein the step of providing neurostimulation therapy further includes utilizing a stimulation vector between the first and second electrodes to capture a targeted nerve branch.
 17. The method of claim 13, wherein the step of arranging includes locating the first electrode adjacent a nerve branch apart from the first location of the nerve.
 18. The method of claim 17, wherein the first location is a main nerve, and further wherein the step of arranging includes positioning the distal extension distally beyond a junction between the main nerve and the nerve branch.
 19. The method of claim 17, wherein the method is characterized by the distal extension not being wrapped about the nerve branch.
 20. The method of claim 13, wherein the step of providing neurostimulation therapy includes treating sleep disordered breathing of the patient. 